← Product Code [IYO](/productcode/IYO) · K973802
# SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM (K973802)
_Shimadzu Medical Systems · IYO · Mar 4, 1998 · Radiology · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K973802
## Device Facts
- **Applicant:** Shimadzu Medical Systems
- **Product Code:** [IYO](/productcode/IYO.md)
- **Decision Date:** Mar 4, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1560
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Indications for Use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
## Device Story
The Shimasonic SDU-450 is a diagnostic ultrasound system utilizing various linear and convex transducers to acquire acoustic signals from the human body. The system processes these signals to generate B-mode, M-mode, and combined B/M-mode images for clinical visualization. Operated by clinicians in a diagnostic setting, the device provides real-time anatomical imaging to assist in the assessment of various clinical conditions across multiple specialties, including abdominal, cardiac, and small organ imaging. The output is displayed on the system monitor for physician interpretation, facilitating clinical decision-making and diagnostic evaluation. The device is intended for prescription use only.
## Clinical Evidence
Bench testing only. The clearance is based on the submission of technical specifications and the requirement for post-clearance acoustic output measurements to ensure compliance with FDA safety levels for diagnostic ultrasound systems.
## Technological Characteristics
Diagnostic ultrasound system using linear and convex array transducers. Supports B-mode, M-mode, and B/M-mode imaging. Operates via piezoelectric sensing. System is a standalone diagnostic unit. Compliance with 21 CFR 820 (Quality System Regulation) and 21 CFR 892.1560/892.1570.
## Regulatory 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.
## Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1998
Yasuharu Ishii Manager Shimadzu Medical Systems 20101 South Vermont Ave. Torrance, California 90502-1328
Re : K973802 Shimasonic SDU-450 Linear/Convex Diagnostic Ultrasound System (Echo View) Dated: January 20, 1998 Received: January 21, 1998 Regulatory class: II 21 CFR 892.1560/21 CFR 892.1570 Procode: 90 IYO/Procode: 90 ITX
Dear Mr. Ishii:
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 Shimasonic SDU-450 System, as described in your premarket notification:
Transducer Model Number
L070-075U L040-100U EL033-075UA 1110-0350 VA13R-035U VA13R-050U VA15R-035U VA15R-050U VA40R-035U VA57R-0375U TV11R-055U TV13R-050U 1072-0500 UB10R-065U
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: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 - Yasuharu Ishii
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 requlations.
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 Therefore, your product labeling must be consistent with FDA's Part 812. CER. 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 incomblete or contains unacceptable values (e.q., 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 Other general information on your responsibilities under the Act may 807.97). 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".
{2}------------------------------------------------
Page 3 -- Yasuharu Ishii
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David W. Bergom
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
Enclosures
. ·
{3}------------------------------------------------
### Ultrasound Device Indications Statement Page _ 1_ of _ 14 _ .
510(k) Number (if known) : K973802 Device Name : Diagnostic Ultrasound System SDU-450, L070-075U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Modes of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | X | X | | | | | | X | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | X | X | | | | | | X | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | X | X | | | | | | X | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments:
- Breast, Thyroid, Testes
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Kynn
---
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
{4}------------------------------------------------
### Page _2__ of __ 14__ . Ultrasound Device Indications Statement
510(k) Number (if known) : _K973802 Device Name : Diagnostic Ultrasound System SDU-450, L040-100U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Modes of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | X | X | X | | | | | | X | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | X | X | | | | | | X | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | X | X | | | | | | X | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
**Modes of Operation**
Additional Comments:
* Breast, Thyroid, Testes
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dev
510(k) Number
**Prescription Use (Per 21 CFR 801.109)**
{5}------------------------------------------------
### Page 3 _ of _ 14_ . Ultrasound Device Indications Statement
510(k) Number (if known) : _K973802 Device Name : Diagnostic Ultrasound System SDU-450, EL033-075UA
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Modes of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | X | X | | | | | | X | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | X | X | | | | | | X | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | X | X | | | | | | X | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments:
- **Breast, Thyroid, Testes**
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluati (ODE)
David C. Ngymm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
**Prescription Use** (Per 21 CFR 801.109)
510(k) Number K973802
{6}------------------------------------------------
### Ultrasound Device Indications Statement Page _ 4_ of _ 14_ .
510(k) Number (if known) : _K973802 Device Name : Diagnostic Ultrasound System SDU-450. L110-035U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Modes of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | X | X | X | | | | | | X | |
| Abdominal | X | X | X | | | | | | X | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
**Modes of Operation**
Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
**510(k) Number** K973802
{7}------------------------------------------------
## Page _ 5__ of __14__ Ultrasound Device Indications Statement
510(k) Number (if known) : _K973802 510(K) Name : Diagnostic Ultrasound System SDU-450, VA13R-035U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Modes of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | X | |
| Abdominal | X | X | X | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | X | X | X | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
## Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Tyson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
{8}------------------------------------------------
### Ultrasound Device Indications Statement Page 6 of __ 14__
510(k) Number (if known) : _K973802 Device Name : Diagnostic Ultrasound System SDU-450, VA13R-050U
Fill out one form for each ultrasound system or transducer.
## Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Modes of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | X | X | | | | | | X | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | | | | | | X | |
| Cardiac Pediatric | | X | X | | | | | | X | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | X | X | | | | | | X | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
tamil G. Seymm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
**Prescription Use (Per 21 CFR 801.109)**
510(k) Number K973802
{9}------------------------------------------------
### Ultrasound Device Indications Statement Page 7 _ of _ 14_
510(k) Number (if known) : _K973802 Device Name : Diagnostic Ultrasound System SDU-450, VA15R-035U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Modes of Operation
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | X | | | | | | X | |
| Abdominal | | X | X | | | | | | X | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | | | | | | X | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Wegman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
{10}------------------------------------------------
### Page _ 8_ of _ 14_ . Ultrasound Device Indications Statement
510(k) Number (if known) : _ K973802 Device Name : Diagnostic Ultrasound System SDU-450, VA15R-050U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Combined Power Color Other CWD Color Clinical Application B M PWD A (Amplitude) Velocity (Specify) ** (Specify) Doppler Doppler Imaging Ophthalmic X Fetal X X X Abdominal X X Intra-operative (Specify) Intra-operative Neurological Pediatric Small Organ (Specify) * Neonatal Cephalic Adult Cephalic Cardiac Adult X X X X Cardiac Pediatric × X Trans-esophageal Trans-rectal Trans-vaginal Intra-luminal Trans-utethral Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (Specify)
Modes of Operation
Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Hyman
Reproductive, Abdominal, El
**Prescription Use (Per 21 CFR 801.109)**
A
4100
{11}------------------------------------------------
### Ultrasound Device Indications Statement Page 9_ of _ 14_ .
## 510(k) Number (if known) : K973802 Device Name : Diagnostic Ultrasound System SDU-450, VA40R-035U
Fill out one form for each ultrasound system or transducer.
## Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| | | | | | | Modes of Operation | | | | |
|----------------------------------|---|---|---|-----|-----|--------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | X | | | | | | X | |
| Abdominal | | X | X | | | | | | X | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | | | | | | X | |
| Cardiac Pediatric | | X | X | | | | | | X | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
f Onemtion
Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Hyson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
{12}------------------------------------------------
# Ultrasound Device Indications Statement Page _10__ of _14_ .
510(k) Number (if known) : _K973802 Device Name : Diagnostic Ultrasound System SDU-450, VA57R-0375U
Fill out one form for each ultrasound system or transducer.
## Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Modes of Operation | | | | | | | | | | |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | X | | | | | | X | |
| Abdominal | | X | X | | | | | | X | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | X | | | | | | X | |
| Cardiac Pediatric | | X | X | | | | | | X | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
SA-----------------
**Additional Comments:**
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Elvin L. Segmen
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
{13}------------------------------------------------
#### Page _ 11_ of _ 14_ . Ultrasound Device Indications Statement
510(k) Number (if known) : _K973802 910(K) Name : Diagnostic Ultrasound System SDU-450, TV11R-055U
Fill out one form for each ultrasound system or transducer.
## Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Modes of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | X | X | | | | | | | X | |
| Trans-vaginal | X | X | | | | | | | X | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
# Modes of Operation
Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (OPE)
David b. Kymm
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices
{14}------------------------------------------------
### Ultrasound Device Indications Statement Page _ 12 _ of _ 14 _ .
## 510(k) Number (if known) : K973802 Device Name : Diagnostic Ultrasound System SDU-450, TV13R-050U
Fill out one form for each ultrasound system or transducer.
Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Modes of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | X | X | | | | | | X | |
| Intra-luminal | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
Modes of Operation
Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Lynn
(Divísion Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
{15}------------------------------------------------
## Ultrasound Device Indications Statement
Page_13 _ of _ 14_ .
510(k) Number (if known) : K973802 Device Name : Diagnostic Ultrasound System SDU-450, L072-050U
Fill out one form for each ultrasound system or transducer.
Indications for use. Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Modes of Operation CWD Color Color Combined Other Clinical Application PWD Power B M A Doppler (Amplitude) Velocity (Specify) ** (Specify) Doppler Imaging Ophthalmic X Fetal X X Abdominal Intra-operative (Specify) Intra-operative Neurological Pediatric Small Organ (Specify) * Neonatal Cephalic Adult Cephalic Cardiac Adult Cardiac Pediatric Trans-esophageal Trans-rectal Trans-vaginal Intra-luminal Trans-utethral Peripheral vessel Laparoscopic Musculo-skeletal X X X Conventional Musculo-skeletal Superficial Other (Specify)
## Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. DeSimone
(Division Sign-Off) 0 Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K973802
{16}------------------------------------------------
## Ultrasound Device Indications Statement
# Page _14 _ of _ 14 _ .
## 5 10(k) Number (if known) : _K973802 510(k) Name : Diagnostic Ultrasound System SDU-450, UB10R-065U
Fill out one form for each ultrasound system or transducer.
## Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
| Modes of Operation | Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Other
(Specify) |
|----------------------------------|----------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Trans-rectal | | X | X | | | | | | X | | |
| Trans-vaginal | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Trans-utethral | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
Modes of Oneration
Additional Comments:
** B/M mode
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Elvin A. Kyner
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number .
---
**Source:** [https://fda-staging.innolitics.com/device/K973802](https://fda-staging.innolitics.com/device/K973802)
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