PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K972973 |
|---|---|
| Device Name | PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Perception, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Oct 15, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The GPS-TUV device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There is no transcranial application for this device.
Device Story
PC-based diagnostic ultrasound system; utilizes mechanical sector and electronic curved array transducers (3.0-12.5 MHz). Inputs: ultrasonic signals from probes; processed to produce 2D real-time images. Modes: B-mode, M-mode, Dual B, Quad B. User interface: alphanumeric keypad, trackball, icon-driven graphical interface. Operated by clinicians in clinical settings. Output: diagnostic images displayed on monitor; used for clinical assessment of abdominal, cardiac, and vascular structures. Benefits: non-invasive visualization of internal anatomy to aid clinical decision-making.
Clinical Evidence
Bench testing only. No clinical data provided. Compliance demonstrated via acoustic output reporting (NEMA UD-2 1992, FDA 1985/1995 guidance) and electrical/electromagnetic safety testing (UL-544, CISPR 11, MIL-STD-462D, IEC 801-2/4).
Technological Characteristics
PC-based architecture; mechanical sector and electronic curved array transducers (fluid-filled design). Frequencies: 3.0-12.5 MHz. Display: 15-inch monitor. Connectivity: SVHS output, NTSC/PAL video compatible, RS-170/CCIR video inputs. Power: 120VAC/60Hz or 240VAC/50Hz. Software: Icon-driven GUI, digital caliper measurements, image archiving/retrieval, report generation.
Indications for Use
Indicated for diagnostic ultrasound imaging of the human body, specifically for general radiology, abdominal, cardiac, and peripheral vascular applications. Patient population includes adults and pediatric patients requiring diagnostic ultrasound. Contraindicated for transcranial applications.
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
- Aloka Co., Model SSD-1700 Ultrasound System and Transducers (K963616)
- Diasonics Ultrasound, Models Synergy (K935024)
- Diasonics Ultrasound, CFM800 (K924079)
- Diasonics Ultrasound, EchoPac (K962662)
- Sharplan Lasers Inc., USight 9010 (K945796)
Submission Summary (Full Text)
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K91271D
EXHIBIT 2
OCT 1 5 1997
# 510 (k) Summary
- Cover PAGE
- 4 Pages of Summary
- 3 pages of Tables
---
8 pages Total
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K972973
EXHIBIT #2 Page 1 of 4
### 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the reguirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
#### Submitter's Identification: 1.
Perception Inc. 9344 N.W. 13th Street, Suite 200 Miami, Florida 33172 Contact Person: Mr. Jimmie Spraker
Date Summary Prepared: August 8, 1997
#### 2. Name of the Device :.
Perception Inc. GPS-TUV Diagnostic Ultrasound System
#### 3. Predicate Device Information:
- Aloka Co., Model SSD-1700 Ultasound System and Transducers, K#963616 1)
- Diasonics Ultrasound, Models Synergy (K#935024), CFM800 (K#924079) 2) and EchoPac (K#962662).
- Sharplan Lasers Inc., USight 9010, K#945796. 3)
#### Device Description: 4.
### General Description
- The GPS-TUV Diagnostic Ultrasound System device is a PC (Computer) based and controlled real time, two-dimensional, mechancial sector and electronic array diagnostic ultrasound system which produces diagnostic ultrasonic images through a user friendly operation.
The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There are no transcranial applications for this device.
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User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-TUV Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS-TUV Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes.
All probes currently intended for use with the Perception Inc. GPS -TUV Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design. Transducer parameters are summarized in the following table:
| PROBE | TYPE | INSP. MODES | APPLIC. |
|---------|-----------|-------------|----------------------------------------|
| GP-3.0 | MECH. SEC | M/B | Gen. Purpose/<br>Abdominal/<br>Cardiac |
| CA-3.5 | CONV. ARR | B | Abdominal |
| PV-12.5 | MECH SEC | M/B | Peripheral<br>Vascular |
#### 5. Intended Use:
The GPS-TUV device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There is no transcranial application for this device.
#### 6. Comparison to Predicate Devices:
We believe the Perception Inc. GPS -TUV Diagnostic Ultrasound System to be substantially equivalent to ultrasound devices currently in commercial distribution in the U.S. A table of comparison outlining similarities and differences between the Perception Inc. GPS -TUV Diaqnostic Ultrasound System and predicate devices is attached to this summary.
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#### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
This 510(k) submission is intended as a Track 1 type submission. Acoustic Output Reporting was prepared utilizing the following documents.
- NEMA 1992, Acoustic output measurement standard for diagnostic ultrasound . equipment, NEMA Standard UD-21992.
- FDA Center for Devices and Radiological Health 1985 510(k) Guide for . Measuring and Reporting and Acoustic Output of Diagnostic Ultrasound Medical Devices, December, 1985, Revised, 1989, 1990, 1991, 1993, 1994 and 1995.
Acoustic output of each system/transducer/mode/application combination was measured and calculated per the above documents. The following testing was conducted which revealed satisfactory testing results and compliance to applicable standards.
- Maximum Acoustic Output Information .
- Estimated In-Situ Intensity .
- . FDA In-Situ Intensity Limits
- Acoustic Output Information for each system/transduc.er/mode ● combination
The following testingwas conducted by a contract testing laboratory:
- UL-544, Third Edition ●
- Radiated and Conducted Emissions per CISPR 11 .
- Magnetic Field Emission per MIL-STD-482D, method RE101 ●
- Electrostatic Discharge Immunity per IEC 801-2 ●
- Radiated Field Immunity (3 V/m, 26 MHZ to 1 Ghz, 100% Square ● Wave Modulation)
- . Steady State Voltage Fluctuations
- Line Voltage Dropouts
- . Slow Line Voltage Sags and Surges
- Fast Transients Bursts per IEC 801-4
- Fast Line Voltage Surges
- Conducted Energy Immunity per MIL-STD-462D, Method CS114
- Magnetic Field Immunity per MIL-STD-482D, Method RS101
- Quasi-Static Electric Field Immunity .
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None of the testing demonstrated any design characteristics that violated the requirements of the "FDA November 1993 Draft Reviewer Guidance for Pre-Market notification submissions, DCRND" or resulted in any safety hazards. It was the contract testing laboratory's conclusion that the device tested met all relevant requirements of the aforementioned guidance testing requirements.
#### Discussion of Clinical Tests Performed: 8.
### Not Applicable
#### 9. Conclusions:
The Perception Inc. GPS-TUV Diagnostic Ultrasound System has the same intended use as a combination of all cited predicates. Al! non-clinical testing and biocompatibility testing revealed no new questions of safety or effectiveness. This, when compared to the predicate devices, the Perception Inc. GPS-TUV Diagnostic Ultrasound System does not incorporate any significant changes in intended use, met: od of operations, material or design that could affect safety or effectiveness.
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| COMPANY<br>SPECS | PERCEPTION INC. | ALOKA CO. | DIASONICS<br>ULTRASOUND | DIASONICS<br>ULTRASOUND | SHARPLAN |
|------------------------------------------------|-------------------------------------|-----------|-----------------------------------|-------------------------|--------------|
| Model | GPS-TUV | SSD-1700 | SYNERGY | CFM800/ECHOPAC | U SIGHT 9010 |
| K # | --- | K 963616 | K935024 | K 924079<br>K 962662 | K 945796 |
| Transducer Type : | | | | | |
| Sector | X | | X | | X |
| Convex Array | X | | X | | |
| Frequencies: | | | | | |
| 3.0 | X | | | | |
| 3.5 | X | | 2-12 | | X |
| 12.5 | X | | | | |
| Gray Scale Levels | 256 | | | | 256 |
| Pre-processing | X | | | | X |
| Post-processing | X | | | | X |
| Digital caliper: | | | | | |
| Distance | X | | | X | X |
| Circumference | X | | | | X |
| Ellipse | X | | | | X |
| Area | X | | | | X |
| Display | | | | | |
| M Mode | X | | | | X |
| B Mode | X | | | X | X |
| M/B | X | | | | X |
| Dual B | X | X | | | |
| PC Based Architecture | X | X | X | X | |
| Hard Disk | X | | X | | |
| Icon/software user interface | X | | X | X | |
| Image Management Archiving/Retrieval | X | X | X | X | |
| | X | X | X | | |
| Measurement Package | X | X | X | X | |
| Storage Patient/study/<br>settings Information | X | X | X | | |
| Report Generation | X | | X | X | |
| Patient Specific Imaging | X | X | X | | |
| Software upgradability | X | | X | | |
| User Programmable Protocols | X | X | | | |
| Network Communications | X | X | ? | X | |
| COMPANY<br>SPECS | PERCEPTION<br>INC | ALOKA CO. | DIASONICS<br>ULTRASOUND | DIASONICS<br>ULTRASOUND | SHARPLAN |
| Applications : | | | | | |
| General Radiology | X | | X | | |
| Abdominal | X | | X | | X |
| Cardiac | X | | | X | |
| Vascular | X | | X | X | |
| Angle | 110° | | | | 110° |
| Image Memory | 512x512x8 | | | | 512x512x8 |
| Frame Rate | 6-31 | | | | 6-15 |
| Display/Labels: | | | | | |
| Image Annotate | X | | | | X |
| Patient ID | X | | | | X |
| Date | X | | | | X |
| Time | X | | | | X |
| Hosp. Name | X | | | | X |
| Application | X | | | | X |
| TGC | X | | | | X |
| Power | X | | | | X |
| Depth | X | | | | X |
| Gain | X | | | | X |
| Probe ID | X | | | | X |
| Softkey Controls | X | | | | X |
| Display Monitor | 15" (K970999) | | 15" | | 13/19" |
| Standard Audio/Video Outputs | | | | | |
| Composite Color | | | | | |
| SVHS Output | X | | X | | X |
| Left/Right Phono<br>connections | X | | X | | X |
| NTSC/PAL Video<br>compatible | X | | X | | X |
| Video Inputs | RS-170/CCIR | | RS-170/CCIR | | |
| Probe connectors | 2 mechanical<br>1 electronic | | 3 mechanical<br>2 electronic | | |
| Alphanumeric Keyboard | X | | X | X | |
| COMPANY<br>SPECS | PERCEPTION<br>INC. | ALOKA CO. | DIASONICS<br>ULTRASOUND | DIASONICS<br>ULTRASOUND | SHARPLAN |
| Options/Accessories | | | | | |
| B/W Video | X | | | | X |
| Graphic Printer | | | | | |
| B/W Video<br>Monitor | X | | | | X |
| S-VHS VCR | X | | | | X |
| Environmental | 5-40° | | 15-33° | | |
| | 5-90% Humidity | | 10-90% Humidity | | |
| Power Consumption | 120VAC,60Hz, 3A<br>240VAC,50Hz,1.5A | | 115VAC,60Hz, 4A<br>230VAC,50Hz,2A | | |
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and the comments of the comments of the country of
ﻪ
:
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Image /page/8/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font. The text is arranged around the circumference of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1997
Ms. Susan D. Goldstein-Falk Perception, Inc. c/o MDI Consultants, Inc. 55 Northern Blvd., Suite 410 Great Neck, NY 11021
K972973 Re:
Perception Inc. GPS-TUV Diagnostic Ultrasound System Dated: August 8, 1997 Received: August 11, 1997 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Ms. Goldstein-Falk:
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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration. listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Perception Inc. GPS-TUV Diagnostic Ultrasound System as described in your premarket notification:
### Transducer Model Number
GP-3.0 General Purpose 3.0 MHz Mechanical Sector CA-3.5 Curved Array 3.5 MHz Electronic PV-12.5 Peripheral Vascular 12.5 MHz Mechanical Sector
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 Regulation (QS) for Medical Devices:
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### Page 2 - Susan D. Goldstein-Falk
General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may 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 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 toll-free number (800) 638-2041 or at (301) 443-6597.
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Page 3 - Susan D. Goldstein-Falk
If you have any questions regarding the content of this letter, please contact Paul Gammell at (301) 594-1212.
Sincerely yours,
Vimid Ca. Slymm
for Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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### GPS-TUV Diagnostic Ultrasound System K972973 GP-3.0 General Purpose 3.0 MHz Mechanical Sector
Intended Use; Diagnostic ultrasound imaging of the human body as follows:
| Clinical | | | | | | Color | Power | Color | Combined | Other |
|-----------------|---|---|---|-----|-----|---------|------------------------|---------------------|-----------|-----------|
| Application | A | B | M | PWD | CWD | Doppler | (Amplitude)<br>Doppler | Velocity<br>Imaging | (Specify) | (Specify) |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | x | x | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| (Specify) | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| (Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | x | x | | | | | | | |
| Trans- | | | | | | | | | | |
| Esophagcal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscalo- | | | | | | | | | | |
| Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo- | | | | | | | | | | |
| Skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments: None
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEEDED)
Prescription Use (Per 21 CFR 801.109)
Clivid A. Seymore
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 73 510(k) Number
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# GPS-TUV Diagnostic Ultrasound System K972973
CA-3.5 Curved Array 3.5 MHz Electronic
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|--------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | x | | | | | | | | |
| Intra-Operative<br>(Specify) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>Esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-<br>Skeletal | | | | | | | | | | |
| Conventional<br>Musculo-<br>Skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments: None
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)
David A. Bergman
(Division Sign-Off)
t Division of Reproductive, Abdominal, ENT, and Radiological Devices 972973 510(k) Number .
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# GPS-TUV Diagnostic Ultrasound System K972973
PV-12.5 Peripheral Vascular 12.5 MHZ Mechanical Sector
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| Clinical | | | | | | Color | Power | Color | Combined | Other |
|------------------------|---|---|---|-----|-----|---------|------------------------|---------------------|-----------|-----------|
| Application | A | B | M | PWD | CWD | Doppler | (Amplitude)<br>Doppler | Velocity<br>Imaging | (Specify) | (Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| (Specify) | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| (Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans- | | | | | | | | | | |
| Esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | x | x | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-<br>Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-<br>Skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments: None
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Pex 21 CFR 801.109)
David A. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_
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# GPS-TUV Diagnostic Ultrasound System K972973
Combined Other Power Color Color Clinical (Specify) (Specify) (Amplitude) Velocity CWD Doppler PWD A B M Application Imaging Doppler Opthalmic Fetal Abdominal × ਮ Intra-Operative (Specify) Intra-Operative Neurological Pediatric Small Organ . • (Specify) Neonatal Cophalic Adult Cephalic Cardiac X x Trans-Esophageal Trans-Rectal Trans-Vaginal Trans-Urethral Intra-Luminal Peripheral メ X Vascular Laparoscopic Musculo-Skelctal Conventional Musculo-Skeletal Superficial Other (Specify)
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
Additional Comments: None
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Usc (Per 21 CFR 801.109)
Javid A. Seymen
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K922473
