Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, DNN, or ML, nor does it describe any features or performance metrics typically associated with AI/ML applications in medical imaging.

Therapeutic

No.
The intended use explicitly states "Diagnostic ultrasound imaging or Doppler analysis" and the device description identifies it as a "mobile diagnostic ultrasound system." It is used for imaging and analysis, not for therapeutic intervention.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or Doppler analysis of the human body". Also, the "Device Description" states "The SDU-1100 is a mobile diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile diagnostic ultrasound system" with "flat linear array, convox array, and sector probe," which are hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: 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 Description: The SDU-1100 is described as a "mobile diagnostic ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or Doppler analysis of the human body." This refers to non-invasive imaging of the body itself, not analysis of samples.

Therefore, the SDU-1100 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

The SDU-1100 is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

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

Clinical Application	B	M	PWD	Color/Doppler	Power (Amplitude) Doppler	Color Velocity Imaging	Combined (Specify)**	Tissue Harmonic Imaging
Ophthalmic
Fetal	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N	N
Intra-operative (Specify)
Intra-operative Neurological
Pediatric
Small Organ (Specify) *	N	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	N	N
Transesophageal
Transrectal	N	N	N	N	N	N	N	N
Transvaginal	N	N	N	N	N	N	N	N
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N	N
Laparoscopic
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N
Other (Specify)

*Other Indications or Modes: * Thyroid, Testicles, Breast ** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)

Product codes

90-IYN, 90-IYO, 90-ITX

Device Description

The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear The SDO Trooms and sector probe with a frequency range of approximately 2 to 15 array, convox mode, M mode, Pulsed Doppler mode, Color mode, or in a combination of modes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Transrectal, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional

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)

GE Logiq 500 (K991611, 6/9/99)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

K0505/0

510(k) Summary

1.0 SUBMITTER INFORMATION

SHIMADZU MEDICAL SYSTEMS 1.1 Submitter: 20101 South Vermont Ave. Torrance, CA 90502-1328 PH: 310-217-8855 FX: 310-217-8869

Randal Walker 1.2 Contact:

January 18, 2005 1.3 Date:

2.0 DEVICE NAME

2.1 Proprietary Name:	SDU-1100
2.2 Common Name:	Ultrasound Imaging System
2.3 Classification:	Ultrasonic Pulsed Doppler Imaging System
FR # 892.1550, Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System
FR # 892.1560, Product Code 90-IYO
Diagnostic Ultrasound Transducer
FR # 892.1570, Product Code 90-ITX
2.4 Predicate Device:	GE Logiq 500 (K991611, 6/9/99)

3.0 DEVICE DESCRIPTION

DE VICE DESCREF TTO!"
The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear The SDO Trooms and sector probe with a frequency range of approximately 2 to 15 array, convox mode, M mode, Pulsed Doppler mode, Color mode, or in a combination of modes.

4.0 INTENDED USE

The SDU-1100 is intended for the following applications:

1

Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

5.0 SAFETY CONSIDERATIONS

SDU-1100 has been designed to meet the following voluntary and measurement standards:

. IEC 60601-1 Safety of Medical Electric Equipment
AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound Equipment
Acoustic Output Measurement and Labeling Standard for Diagnostic . Ultrasound Equipment Revision 1 (AIUM 1998)
. AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2005

Mr. Randal Walker National Service Manager Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502

Re: K050510

Trade Name: SDU-1100 (Echo View/Shimasonic) Diagnostic Ultrasound Device Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 18, 2005 Received: March 1, 2005

Dear Mr. Walker:

We have reviewed your Section 510(k) premarket 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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the SDU-1100 (Echo View/Shimasonic) Diagnostic Ultrasound Device, as described in your premarket notification:

Transducer Model Number

L040-075U	L072-050U
L040-120U	VA13R-035U
L070-075U	VA13R-050U

3

VA20R-035U	VA57R-0375HU
VA40R-035U	TV11R-055U
VA40R-035HU	UB10R-065U
VA57R-0375WU

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your do received to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of a has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny 1 outher the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quand byovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 m rippendines of the counce of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at not 10. Jose (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain

4

Page 2 - Mr.Walker

other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

5

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement

Page 1 _ of _ 14

510(k) Number (if known) : 510(K) Namber (II known) : Ultrasound System SDU-1100, system

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:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Power (Amplitude) Doppler	Color Velocity Imaging	Combined (Specify)**	Tissue Harmonic Imaging	Other (Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N	N
Abdominal		N	N	N		N	N	N	N	N
Intra-operative (Specify)
Intra-operative Neurological
Pediatric
Small Organ (Specify) *		N	N	N		N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N	N	N	N
Transesophageal
Transrectal		N	N	N		N	N	N	N	N
Transvaginal		N	N	N		N	N	N	N	N
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N	N	N	N
Laparoscopic
Musculo-skeletal Conventional		N	N	N		N	N	N	N	N
Musculo-skeletal Superficial		N	N	N		N	N	N	N	N
Other (Specify)

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

Thyroid, Testicles, Breast

** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Nancy bradom
(Division Sign-Off)

Division of and Radiological Device 510(k) Number

6

Prescription Use (Per 21 CFR 801.109) Page 2 of _ 14 Ultrasound Device Indications Statement

510(k) Number (if known) : 510(K) Numoci (II Known) :
Device Name : Diagnostic Ultrasound System SDU-1100, L040-075U

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:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify)** | Tissue
Harmoni
c
Imaging | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-----------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | N | N | N | | N | N | N | N | N | N |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N | N | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | N | N | N | | N | N | N | N | N | N |
| Musculo-skeletal
Superficial | | N | N | N | | N | N | N | N | N | N |
| Other (Specify) | | | | | | | | | | | |

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

- Thyroid, Testicles, Breast
  ** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Vance Snagdon

(Division Sign-C Division of Reproductive, Abdon and Radiological Device 510(k) Number

7

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 3 _of _ 14

510(k) Number (if known) : 510(K) Number (II Known) .
Device Name : Diagnostic Ultrasound System SDU-1100, L040-120U

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:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *		N	N	N		N	N	N	N	N
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N	N	N	N
Laparoscopic
Musculo-skeletal
Conventional		N	N	N		N	N	N	N	N
Musculo-skeletal
Superficial		N	N	N		N	N	N	N	N
Others (Specify)

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

Thyroid, Testicles, Breast

** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)

Conversion Algae

(Division Sign-Off)
Nancy Brandon

Division of Reproductive and Radiological Device 510(k) Number

8

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 4_of __ 14

510(k) Number (if known) : 510(K) Name : Diagnostic Ultrasound System SDU-1100, 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:

						Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *		N	N	N		N	N	N	N	N
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N	N	N	N
Laparoscopic
Musculo-skeletal
Conventional		N	N	N		N	N	N	N	N
Musculo-skeletal
Superficial		N	N	N		N	N	N	N	N
Others (Specify)

ode of Oneration

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

Thyroid, Testicles, Breast

** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)

Criminology Class

✓

Nancy C. Brigdon

(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number

9

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 5 of 14

510(k) Number (if known) : 510(K) Name : Diagnostic Ultrasound System SDU-1100, 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:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify)**	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *		N	N	N		N	N	N	N	N
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N	N	N	N
Laparoscopic
Musculo-skeletal
Conventional		N	N	N		N	N	N	N	N
Musculo-skeletal
Superficial
Others (Specify)

Ennoration

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

Thyroid, Testicles, Breast

** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)

$\checkmark$

Nancy C. Bradden

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510jk) Number

10

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 6 _ of _ 14

510(k) Number (if known) : 510(K) Number (11 Kilowil) ·
Device Name : Diagnostic Ultrasound System SDU-1100, 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:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify)**	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal	N	N	N	N		N	N	N	N	N
Abdominal	N	N	N	N		N	N	N	N	N
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac	N	N	N	N		N	N	N	N	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)

Nancy C. Broadson

(Division Sign-Off) Division of Reproductive, Abdomit and Radiological Devices 510(k) Number

11

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 7 _ of __ 14 _

510(k) Number (if known) : 310(K) Name : Diagnostic Ultrasound System SDU-1100, 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:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal	N	N	N	N		N	N	N	N	N
Abdominal	N	N	N	N		N	N	N	N	N
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N	N	N	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)

/

Nancy Choadon

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _

12

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 8 of 14

510(k) Number (if known) : 510(K) Number (II Khown) ·
Device Name : Diagnostic Ultrasound System SDU-1100, VA20R-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:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify)**	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N	N
Abdominal		N	N	N		N	N	N	N	N
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N	N	N	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

of Oneration

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)

Nancy C Hogdon
(Division Sign-Off)

Division of Reproductive, Abdon and Radiological Devices 5 10(k) Number

13

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 9 of _ 14

510(k) Number (if known) : 510(K) Name : Diagnostic Ultrasound System SDU-1100, 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:

Mode of Operation
Clinical
Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N	N
Abdominal		N	N	N		N	N	N	N	N
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Oneration

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)

$\checkmark$

Nancy C. hogdon

(Division Sign Off) Division of Reproductive, Abdo and Radiological Devices 5 10(k) Number

14

Prescription Use (Per 21 CFR 801.109) Page _ 10_ of _ 14 Ultrasound Device Indications Statement

510(k) Number (if known) : 510(K) Name : Diagnostic Ultrasound System SDU-1100, VA40R-035HU

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:

Mode of Operation
Clinical
Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal	N	N	N	N		N	N	N	N	N
Abdominal	N	N	N	N		N	N	N	N	N
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)

Nancy C. Hogdon

(Division Sigh-Off) Division of Reproductive, Abdominal, ഒരു പ്രവേശ്വാcal Devices ി

15

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 11_ of _ 14

510(k) Number (if known) : 510(K) Number (11 Khowil) .
Device Name : Diagnostic Ultrasound System SDU-1100, VA57R-0375WU

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:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) ** | Tissue
Harmonic
Imaging | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N | N | |
| Abdominal | | N | N | N | | N | N | N | N | N | |
| Intra-operative
(Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

ode of Oneration

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)

$\checkmark$

Nancy L. Tharpion
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(K) Number K0505

16

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 12_of 14

510(k) Number (if known) : 510(K) Number (11 khowil) · Litrasound System SDU-1100, VA57R-0375HU

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:

Mode of Operation
Clinical
Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify)**	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal	N	N	N	N		N	N	N	N	N
Abdominal	N	N	N	N		N	N	N	N	N
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brazdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
adiological Devices
K Number
K05

300(k) Number _

17

Prescription Use (Per 21 CFR 801.109) Page _ 13_ of _ 14 Ultrasound Device Indications Statement

510(k) Number (if known) : 510(K) Number (II Khowi) · ___________________________________________________________________________________________________________________________________________________

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:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	N	N	N
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal										N
Transrectal		N	N	N		N	N	N	N	N
Transvaginal		N	N	N		N	N	N	N	N	N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Oneration

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)

V

Nancy C burton

(Division Sign-Off)(
Division of Reproductive, Abdominal,
and Darkh al Devices
amber
K050510

18

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _14 of 14

510(k) Number (if known) :

510(K) Name : Diagnostic Ultrasound System SDU-1100, 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:

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) **	Tissue
Harmonic
Imaging	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N	N	N	N
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Operation

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)

Maneyl beagdon
(Division Sign-Off)

U
of Reproductive, Abdominal,
Radiological Devices
510(k) Number L050510

Intended Use / Indications for Use

Product codes

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)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 892.1550 Ultrasonic pulsed doppler imaging system.

510(k) Summary

1.0 SUBMITTER INFORMATION

2.0 DEVICE NAME

3.0 DEVICE DESCRIPTION

4.0 INTENDED USE

5.0 SAFETY CONSIDERATIONS

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement

Prescription Use (Per 21 CFR 801.109) Page 2 of _ 14 Ultrasound Device Indications Statement

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 3 _of _ 14

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 4_of __ 14

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 5 of 14

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 6 _ of _ 14

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 7 _ of __ 14 _

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 8 of 14

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 9 of _ 14

Prescription Use (Per 21 CFR 801.109) Page _ 10_ of _ 14 Ultrasound Device Indications Statement

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 11_ of _ 14

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 12_of __ 14__

Prescription Use (Per 21 CFR 801.109) Page _ 13_ of _ 14 Ultrasound Device Indications Statement

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _14 of 14

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 12_of 14