Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not mention AI, ML, deep learning, or any related terms, nor does it describe features or functionalities typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis based on learned patterns).

Therapeutic

No.
The intended use explicitly states "Diagnostic ultrasound imaging or Doppler analysis," indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or Doppler analysis of the human body". The "Device Description" also refers to it as a "Diagnostic Ultrasound System".

SaMD (Software as a Medical Device)

No

The device description explicitly states "Diagnostic Ultrasound System SDU-450 with various transducer models," indicating the presence of hardware components (the ultrasound system and transducers) in addition to any potential software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this is a "Diagnostic ultrasound imaging or Doppler analysis of the human body." Ultrasound is a non-invasive imaging technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Intended Use/Indications for Use: The listed clinical applications are all related to imaging and analysis of internal anatomy and blood flow within the body.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

L070-075U: Small Organ (Breast, Thyroid, Testes), Peripheral vessel, Musculo-skeletal Conventional
L040-100U: Small Organ (Breast, Thyroid, Testes), Peripheral vessel, Musculo-skeletal Conventional
EL033-075UA: Small Organ (Breast, Thyroid, Testes), Peripheral vessel, Musculo-skeletal Conventional
L110-035U: Fetal, Abdominal
VA13R-035U: Fetal, Abdominal, Cardiac Adult
VA13R-050U: Abdominal, Cardiac Adult, Cardiac Pediatric, Peripheral vessel
VA15R-035U: Fetal, Abdominal, Cardiac Adult
VA15R-050U: Fetal, Abdominal, Cardiac Adult, Cardiac Pediatric
VA40R-035U: Fetal, Abdominal, Cardiac Adult, Cardiac Pediatric
VA57R-0375U: Fetal, Abdominal, Cardiac Adult, Cardiac Pediatric
TV11R-055U: Trans-rectal, Trans-vaginal
TV13R-050U: Trans-vaginal
L072-050U: Ophthalmic, Fetal, Musculo-skeletal Conventional
UB10R-065U: Trans-rectal

Product codes (comma separated list FDA assigned to the subject device)

90 IYO, 90 ITX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Abdominal, Intra-operative, Intra-operative Neurological, Pediatric, Small Organ (Breast, Thyroid, Testes), Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Trans-esophageal, Trans-rectal, Trans-vaginal, Intra-luminal, Trans-urethral, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.

Summary

0

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 .

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 892.1560 Ultrasonic pulsed echo imaging system.

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Additional Comments:

Ultrasound Device Indications Statement Page 6 of __ 14__

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Ultrasound Device Indications Statement Page 7 _ of _ 14_

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Ultrasound Device Indications Statement Page 9_ of _ 14_ .

510(k) Number (if known) : K973802 Device Name : Diagnostic Ultrasound System SDU-450, VA40R-035U

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Ultrasound Device Indications Statement Page 10_ of 14 .

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Page _ 11_ of _ 14_ . Ultrasound Device Indications Statement

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Modes of Operation

Ultrasound Device Indications Statement Page _ 12 _ of _ 14 _ .

510(k) Number (if known) : K973802 Device Name : Diagnostic Ultrasound System SDU-450, TV13R-050U

Ultrasound Device Indications Statement

Additional Comments:

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

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

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