GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K992208 |
|---|---|
| Device Name | GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Ge Medical Systems, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Jul 12, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The GE LOGIQ 200 MD is a general purpose imaging system intended for use in obstetrics, gynecology, urology and general radiology examinations by a qualified physician to aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data. Specific Clinical applications included in the indications for use are: Fetal. Abdominal. Intraoperative (abdominal), Pediatric, Small organs (breast, male and female reproductive organs, limbs & extremities), Adult cephalic, Cardiac (adult & pediatric), Transvaginal, Transrectal and Urological.
Device Story
Mobile diagnostic ultrasound console (approx. 75 kg) for B, M, and B/M mode imaging. Inputs: ultrasonic pulsed echo signals from linear, convex, micro-convex, or phased array probes. System processes signals to generate 2D images, time-motion images, and biometric data for clinical diagnosis. Operated by physicians in clinical settings. Output displayed on monochrome monitor for visual assessment of soft tissues. Benefits include non-invasive diagnostic evaluation of various anatomical structures and physiological states.
Clinical Evidence
Bench testing only. No clinical data required. Device evaluated for acoustic output, biocompatibility, and thermal, electrical, and mechanical safety per FDA guidelines and ISO 9001/13485 standards.
Technological Characteristics
Mobile console (40x60x125 cm, 75 kg). Supports linear, convex, micro-convex, and phased array transducers. Modes: B, M, B/M. Connectivity: monochrome video monitor. Design conforms to 21 CFR 820, ISO 9001, and ISO 13485. Acoustic output verified per FDA guidelines.
Indications for Use
Indicated for fetal, abdominal, intraoperative (abdominal), pediatric, small organ (breast, reproductive organs, limbs/extremities), adult/pediatric cephalic, cardiac, transvaginal, transrectal, and urological ultrasound imaging. For use by qualified physicians.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- GE LOGIQ a200 Diagnostic Ultrasound System (K960700)
Submission Summary (Full Text)
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K 992208
# Section 2:
Summary of Safetv and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/6 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular border. The logo is black and white.
1.
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
### Section a):
| Submitter: | GE Medical Systems PO Box 414 Milwaukee, WI 53201 |
|-----------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | Allen Schuh, Manager, Safety and Regulatory Engineering Telephone: 414-647-4385, Fax: 414-647-4090 |
| Date Prepared: | May 24, 1999 |
- 2. Device Name: GE LOGIQ 200 MD Diagnostic Ultrasound System Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
3. Marketed Device: GE LOGIQ a200 Diagnostic Ultrasound System - K960700, 28 AUG 1996
4. Device Description: The GE LOGIQ 200 MD consists of a mobile console approximately 40 cm wide, 60 cm deep and 125 cm high, weighing approximately 75 kg. The user interface consists of a keyboard and monochrome video monitor. The system is designed for use in B, M and B/M scanning modes and supports linear, convex, micro convex and phased array probes.
5. Indications for Use: The GE LOGIQ 200 MD is a general purpose imaging system intended for use in obstetrics, gynecology, urology and general radiology examinations by a qualified physician to aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data. Specific Clinical applications included in the indications for use are: Fetal. Abdominal. Intraoperative (abdominal), Pediatric, Small organs (breast, male and female reproductive organs, limbs & extremities), Adult cephalic, Cardiac (adult & pediatric), Transvaginal, Transrectal and Urological.
6. Comparison with Predicate Device: The GE LOGIQ 200 MD Diagnostic Ultrasound System is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ o200. It has similar technological characteristics, is comparable in key safety and effectiveness features, uses the same general design, construction, and materials, and has the same intended uses and operating modes as the predicate device.
### Section b):
1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. The ultrasound generator modifications require re-verification of the acoustic output levels which will be provided in the 510(k) special report.
2. Clinical Tests: None required.
3. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & 13485 quality sytem standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing production surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 200 MD is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1:2 1999
General Electric Medical Systems c/o Chantel Carson Engineering Services Underwriters Laboratories, Inc. 353 Pfingsten Road Northbrook, IL 60062-2096
K992208 Re: Trade Name: GE LOGIQ 200 MD Diagnostic Ultrasound System Regulatory Class: II Product Code: 90-IYO and 90-ITX Dated: June 22, 1999 Received: June 30, 1999
Dear Ms. Carson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the GE LOGIQ 200 MD Diagnostic Ultrasound System, as described in your premarket notification:
#### Transducer Model Numbers
CBF, CAE, MTZ, CZB, LH, LE, LL, LT, LB, CS, 9Lb, SY, ERB, and 3Cb
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such Failure to comply with the GMP regulation may result in assumptions.
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Page 2 - Ms. Chantel Carson
In addition, the Food and Drug Administration (FDA) may requlatory action. publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G,
(enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
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If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D. at (301) 594-1212.
Sincerely yours,
CAPT. Daniel G. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director Division of Reproductive, Abdominal, Ear, Nose, and Throat, and Radiology Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Page 4 - Ms. Chantel Carson
cc: HFZ-401 HFZ-470 D.O.
draft: final:RAPhillips:7.9.99
.
.
۱
:
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### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD System
Intended Use: 2D ultrasound imaging or motion analysis as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | | | | | | P | | | |
| Abdominal | | P | P | | | | | | P | | | |
| Intraoperative (specify) | | P | P | | | | | | P | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | | P | P | | | | | | P | | | |
| Neonatal Cephalic | | P | P | | | | | | P | | | |
| Adult Cephalic | | P | P | | | | | | P | | | |
| Cardiac | | P | P | | | | | | P | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | P | P | | | | | | P | | | |
| Transvaginal | | P | P | | | | | | P | | | |
| Transuretheral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | P | P | | | | | | P | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Cardiac is Adult and Pediatric. Small Organ includes: breast, neck, chest, male and female reproductive organs, limbs, & extremities. Other includes urological. Intraoperative includes abdominal organs. Combined mode is B/M. Previous market clearance: K960700
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
Prescription User (Per 21 CFR 801.109)
510(k) Number K992208
{6}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with CBF Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | | | | | | P | | |
| Abdominal | | P | P | | | | | | P | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M.
Previous market clearance: K960700
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE), (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K992208 Prescription Usef (Per 21 CFR 801.109)
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### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with CAE Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | P | |
| Abdominal | | P | P | | | | | | P | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | | | | | | P | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M. Cardiac includes adult and pediatric.
Previous market clearance: K960700
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Prescription User (Per 21 CFR 801.109) 510(k) Number
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### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with MTZ Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | P | |
| Abdominal | | P | P | | | | | | P | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | | | | | | P | |
| Transvaginal | | P | P | | | | | | P | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | P | P | | | | | | P | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M. Other includes urological.
Previous market clearance: K960700
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
(Division-Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992208
{9}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with CZB Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | P | P | | | | | | P | |
| Neonatal Cephalic | | P | P | | | | | | P | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M.
Previous market clearance: K960700
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
Prescription User (Per 21 CFR 801.109)
510(k) Number K99 2208
1
{10}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with LH Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | P | P | | | | | | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Small Organ includes: breast, neck, chest, male and female reproductive organs, limbs, & extremities. Combined mode is B/M. Previous market clearance: K960700
> (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)) Concurrence of CDRH, Office of Device Evaluation (ODE)
$$\swarrow$$
Prescription User (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
1
510(k) Number_K 99 2 2 08
{11}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with LE Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | | Mode of Operation | | | | | | | | | |
|-------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | | | | | | P | | |
| Abdominal | | P | P | | | | | | P | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M.
Previous market clearance: K960700
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED),
Concurrence of CDRH, Office of Device Evaluation (ODE).
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number_K 99 2208
Prescription User (Per 21 CFR 801.109)
1
{12}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with LI Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | | | | | | P | |
| Intraoperative (specify) | | P | P | | | | | | P | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M.
Previous market clearance: K960700
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Intraoperative includes abdominal organs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---------------------|--|
|---------------------|--|
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number_1 492208
C Prescription User (Per 21 CFR 801.109)
{13}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with LT Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | | | | | | P | |
| Intraoperative (specify) | | P | P | | | | | | P | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M.
Previous market clearance: K960700
Intraoperative includes abdominal organs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED); ' Concurrence of CDRH, Office of Device Evaluation (ODE)
ER PAGE IF NEEDED)
ation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number . 492208
C Prescription User (Per 21 CFR 801.109)
A-9
{14}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with LB Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | P | |
| Abdominal | | P | P | | | | | | P | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M.
Previous market clearance: K960700
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
2208 510(k) Number _
1
{15}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with LD Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | | | | | | P | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M.
Previous market clearance: K960700
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uation (ODE)
Division Sign-Off)
Prescription User (Per 21 CFR 801.109)
C
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
{16}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with CS Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | |
| Abdominal | | N | N | | | | | | N | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Cardiac is Adult and Pediatric. Combined mode is B/M.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number KG922 OF
{17}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
## GE LOGIQ 200 MD with 9Lb Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | N | N | | | | | | N | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined mode is B/M. Small organ includes: breast, neck, chest, male and female reproductive organs, limbs, & extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
6 Prescription User (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number_ KGG 2208
{18}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 200 MD with SY Transducer
Intended Use: 2D ultrasound imaging or motion analysis:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | |
| Abdominal | | N | N | | | | | | N | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | |
| Transesophageal | | | | | | | |…
