Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states that the only modifications were related to the power supply (changing from AC to battery) and accompanying labeling changes. There is no mention of any software or algorithmic changes, particularly those related to AI or ML. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".

Therapeutic

No
The device is described as an ultrasonic imaging instrument intended for diagnostic purposes, not for therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states the device is an "ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ... etc.", and the "Device Description" explicitly mentions it is "intended for clinical diagnostic imaging applications." Furthermore, the predicate device it is compared to is named the "SonoScape S8 Diagnostic Ultrasound System".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and details a change in its power supply from AC to battery, indicating it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device is a "general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ...". This describes a device used for imaging the body directly, not for testing samples (like blood, urine, or tissue) outside of the body.
Device Description: The description focuses on the ultrasound imaging capabilities and the power source change. It does not mention any components or functions related to analyzing biological samples.
Input Imaging Modality: The input modality is "Diagnostic Ultrasound," which is an imaging technique applied to the patient's body.
Anatomical Site: The listed anatomical sites are all parts of the human body.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is used for direct imaging of the body, which falls under the category of medical imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology. This is the same intended use as previously cleared for the SonoScape S8 Diagnostic Ultrasound System, K092922.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Fetal Imaging & Other: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ob/GYN
Cardiac: Cardiac Adult, Cardiac Pediatric
Peripheral Vessel: Peripheral vessel

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

1YN, 1YO, ITX

Device Description

The SonoScape S8 Ultrasound System, previously cleared under K092922, is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The only modifications that were made are: The original S8 Diagnostic Ultrasound System, was previously cleared in K092922 dated March 12, 2009, uses an internal SMPS as its power supply system. And the proposed device was redesigned, changing from AC to battery power, i.e. the internal Li-ion Battery Pack (with an external AC adapter). Such a change is accompanied by labeling changes, but not including new indication for use (See Tab 3).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn, Urology, Intra-operative Neuro, Laparoscopic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card), Intravascular, Intra-cardiac

Indicated Patient Age Range

Pediatric, Neonatal, Adult, Fetal

Intended User / Care Setting

Qualified physician

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)

Laboratory testing was conducted to verify that the S8 Diagnostic Ultrasound System met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".

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.

K092922

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

§ 892.1550 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

K112451

S8 Diagnostic Ultrasound System

Tab 19 PREMARKET NOTIFICATION 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

Manufacturer:

SonoScape Company Limited

Address: 4/F., Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051,

P.R.China

Tel: (86) 755-26722890

Fax: (86) 755-26722850

Contact Person: Chen Zhiqiang

Date Prepared: July 12, 2011

Name of the device:

- Trade/Proprietary Name:
S8 Diagnostic Ultrasound System
- Common Name: Diagnostic Ultrasound System and Transducers
- Classification:

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

Legally Marketed Predicate Device:

K092922, SonoScape S8 Diagnostic Ultrasound System

Premarket Notification 510(k) Summary

1

Device Description:

The SonoScape S8 Ultrasound System, previously cleared under K092922, is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The only modifications that were made are:

The original S8 Diagnostic Ultrasound System, was previously cleared in K092922 dated March 12, 2009, uses an internal SMPS as its power supply system. And the proposed device was redesigned, changing from AC to battery power, i.e. the internal Li-ion Battery Pack (with an external AC adapter). Such a change is accompanied by labeling changes, but not including new indication for use (See Tab 3).

Table 21.1 lists the differences between the two power supply systems.

| Model
Item | S8
K092922
(with SMPS) | S8
TBD
(with Battery Pack and AC Adapter) |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power
supply | No battery pack is provided;
The SMPS forms the power
supply system. | An internal battery pack is provided;
The power supply system consists of
the AC adapter and DC converter
and a Li-ion Battery Pack. |
| Working
Principle of
the Power
Supply | The SMPS converts the 220V
or 110V mains voltage to the
DC voltages (+12V, -12V, +5V,
+3.3V, +5VSB) required by all
the electronic parts in the S8
Series System. | The AC adapter converts the mains
voltage (100-240V AC) to a DC
voltage of approximately +17.5V.
Supplied with this DC voltage, the
DC converter charges the battery
and also converts the DC voltage to
the lower voltages (+12V, -12V, +5V,
+3.3V, +5VSB) required by all the
electronic parts in the S8 system,
and at the same time controls the
LED indicators on the control
panel/keyboard. |

Table 21.1 Comparison of the Switching Mode Power Supply (SMPS) System and the Battery Pack Power Supply System

2

SonoScape Company LTD	S8 Diagnostic Ultrasound System
Model
Item	S8
K092922
(with SMPS)	S8
TBD
(with Battery Pack and AC Adapter)
Control
Panel/
Keyboard	/	Compared to control panel of the
original certified product, three LEDs
have been added at the bottom right
corner of the control panel.
Remarks	1)Since the original S8 System does not have internal battery, it
requires the mains supply to operate. When no mains supply is
provided, the system can not be turned on.
2)With the Li-ion Battery Pack, the S8 System can operate even
when no mains supply is available.

Intended Use:

The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology. This is the same intended use as previously cleared for the SonoScape S8 Diagnostic Ultrasound System, K092922.

Probe Information:

No.	Probe	Type	Frequency Range	Intended Use
1	2P1	Phased Array	2.0-4.0 MHz	Abdominal
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
2	5P1	Phased Array	3.0-7.0 MHz	Pediatric
Neonatal Cephalic
Cardiac Pediatric
3	6V1	Micro-curved
Array	4.0-8.0 MHz	Trans-rectal
Trans-vaginal
4	6V3	Micro-curved
Array	5.0-9.0 MHz	Trans-rectal
Trans-vaginal
5	EC9-5	Micro-curved
Array	5.0-9.0 MHz	Trans-rectal
Trans-vaginal
6	C611	Micro-curved
Array	4.0-8.0 MHz	Abdominal
Pediatric
Neonatal Cephalic
Cardiac Pediatric

Tab 21.2 Probe information

Premarket Notification 510(k) Summary

3

SonoScape Company LTD

S8 Diagnostic Ultrasound System

No.	Probe	Type	Frequency Range	Intended Use
7	C344	Curved Array	2.0-5.0 MHz	Fetal / Abdominal/ Ob/GYN
8	C362	Curved Array	2.0-6.0 MHz	Fetal / Abdominal/ Ob/GYN
9	VC6-2	Curved Array	2.0-6.0 MHz	Fetal / Abdominal/ Ob/GYN
10	L741	Linear Array	5.0-10.0 MHz	Small Organ (breast, thyroid, testes)
Musculo-skeletal (Conventional)
Peripheral vessel
11	L742	Linear Array	5.0-12.0 MHz	Small Organ (breast, thyroid, testes)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel
12	L743	Linear Array	5.0-10.0 MHz	Small Organ (breast, thyroid, testes)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Peripheral vessel

Safety Considerations:

The S8 Diagnostic Ultrasound System incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 9, 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5 and ISO 10993-10.

Testing:

Laboratory testing was conducted to verify that the S8 Diagnostic Ultrasound System met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to

4

SonoScape Company LTD

conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".

Standards No.	Standards Title	Version
IEC 60601-1	IEC 60601-1, Medical Electrical Equipment - Part 1:
General Requirements for Safety, 1988;
Amendment 1, 1991-11, Amendment 2, 1995.	1988	10/31/2005
IEC 60601-1-2	IEC 60601-1-2, (Second Edition, 2001), Medical
Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and
Tests.	2007	07/31/2008
IEC
60601-2-37	IEC 60601-2-37 (2004) (2005) Amendment 2,
Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment.	2007	09/08/2009
NEMA UD 2	NEMA UD 2-2004, Acoustic Output Measurement
Standard for Diagnostic Ultrasound Equipment
Version 3.	2004	09/08/2009
ISO 10993-5	ISO 10993-5:1999, Biological evaluation of medical
devices -- Part 5: Tests for In Vitro cytotoxicity.	2009	09/12/2007
10993-10	ISO 10993-10:2002, Biological evaluation of
medical devices - Part 10: Tests for irritation and
delayed-type hypersensitivity.	2002	09/12/2007

Tab 21.3 Applicable Safety Standards

Conclusion:

The conclusions drawn from testing of the S8 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

5

Image /page/5/Picture/1 description: The image shows a logo with a stylized bird-like symbol on the right and a circular arrangement of text on the left. The text appears to be "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES". The bird-like symbol is composed of curved lines, giving it a sense of motion or flight.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

SonoScape Company Limited % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 237-023 Shanghai, 200237 CHINA

SEP 16 2011

Re: K112451

Trade/Device Name: S8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, 1YO, and ITX Dated: August 24. 2011 Received: August 25. 2011

Dear Ms. Hong:

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 S8 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

2P1 Phase Arrav 5P1 Phase Array 6V ! Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Arrav C611 Micro-curved Array C362 Curved Array C344 Curved Array

VC6-2 Curved Array L743 Linear Array L741 Linear Array L742 Linear Array

6

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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. 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 that FDA 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 comply with all 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing vour 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy, Ph.D. at (301) 796-6242.

Sincerely Yours.

Mary S Postiff

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

7

Tab 3 Indications For Use

510(k) Number: Device Name: S8 Diagnostic Ultrasound System

Indications for Use: The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

May S. Patel

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K112451

8

System: Sonoscape S8 Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4,5
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2,4,6
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 24
	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2, 4
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4,5
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2
	Other (specify)

N = new indication;

Prescription Use

P = previously cleared by FDA;

E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

(Part 21 CFR 801 Subpart D)

Note 5: 4D

Note 3: TDI Note 6: Small Organ: breast, thyroid, testes

X

Note 4: 3D

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

510

Mary S. Patel

(Division Sign Off)

Indications For Use

Division Sign Division of Pradiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K112451

3-2

9

Transducer: 2P1 Phase Array

Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&	Fetal
Other	Abdominal	P	P	P		P	P	Note 1	Notes 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel
Vessel	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M: B/PWD: B/THI; M/Color M : B/Color Doppler; B/Color Doppler;PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Note 5: 4D

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Man S. Patel

sion Sio Division of Radiological D Office of In

610K K112451

3-3

Indications For Use

10

Transducer: 5P1 Phase Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

P = previously cleared by E

appendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Note 5: 4D

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Indications For Use

Mary S. Patel
3-4

Division of Radiological Di Office of In Vitro Diagnostic De

510K

11

Transducer: 6V1 Micro-curved Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&
Other	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)
N = new indication;	Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power
Doppler/PWD			P = previously cleared by FDA;				E = added under this appendix
	Note 2: Tissue Harmonic Imaging.
Note 3: TDI	Note 4: 3D			Note 5: 4D
	Note 6: Small Organ: breast, thyroid, testes
Prescription Use	X			AND/OR				Over The Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Indications For Use

Maus. Potel 3-5
(Division Sign-Off)

Division of Radiologica Office of In and Sefety

510K K1124/S1

12

Transducer: 6V3 Micro-curved Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation					Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)
N = new indication;
P = previously cleared by FDA;
E = added under this appendix

P = previously cleared by FDA;

E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Note 5: 4D

Over-The-Counter Use _ . (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Indications For Use

Mays Patel
(Division Sign-Off)

Division of Radiological Devices Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
I

510K K12451

3-6

13

Transducer: EC9-5 Micro-curved Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation					Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)
P = previously cleared by FDA;
E = added under this appendix
N = new indication;

P = previously cleared by FDA;

E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 5: 4D

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

・

Indications For Use

Mary S Patel 3-7
(Division Sign-Off)

Office of In and Safety

510K

14

Transducer: C611 Micro-curved Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation						Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal	P	P	P		P	P	Note 1	Notes 2
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2
	Small Organ (specify)
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler; WD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

Note 5: 4D

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Masa S. Patil 3-8
(Division Sign Off)

Division of Office of In and Safety

$$K_{112/1} \leq 1$$

510k

Indications For Use

15

Transducer: C362 Curved Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation					Other*
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Combined	Specify
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4
	Abdominal	P	P	P		P	P	Note1	Notes 2,4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)
N = new indication:
P = previously cleared by FDA:
E = added under this annendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH): M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 4: 3D Note 3: TDI

Note 6: Small Organ: breast, thyroid, testes

Note 5: 4D

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel
(Division Sign-Off)

Indications For Use

3-9 Division of Radiological De Office of In Vitro Diagnostic Device Evaluation and Safety

510K K1124S1

16

Transducer: C344 Curved Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal	P	P	P		P	P	Note 1	Notes 2, 4
	Abdominal	P	P	P		P	P	Note 1	Notes 2, 4
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2, 4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)
N = new indication;		P = previously cleared by FDA;
E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

(Part 21 CFR 801 Subpart D)

Note 6: Small Organ: breast, thyroid, testes

X

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 5: 4D

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Indications For Use

Prescription Use

Mury Statt 3-10
(Division Sign-Off)

itro Diagnostic Device valuation and Safety

510F

17

Transducer: VC6-2 Curved Array

Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic					P
Fetal
Imaging &
Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4,5
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4,5
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel
	Other (specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

(Part 21 CFR 801 Subpart D)

Note 6: Small Organ: breast, thyroid, testes

X

1

AND/OR

Note 5: 4D

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Indications For Use

Prescription Use

Marr S. Rotel 3-11
(Division Sign-Off)

and Safety

510k

18

Transducer: L743 Linear Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal	Fetal
Imaging&
Other	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2, 4
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2, 4
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2, 4
Vessel	Other (specify)
P = previously cleared by FDA:
E = added under this appendix
N = new indication:

Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 4: 3D Note 3: TDI

Note 6: Small Organ: breast, thyroid, testes

Note 5: 4D

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVI)

es (OIVD)

(Division Sign Off)

Division of Badin Office of It

510K K11245-1

Indications For Use

19

Transducer: L741 Linear Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2, 4
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2, 4
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2, 4
	Other (specify)
N = new indication;	P = previously cleared by FDA;							E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/TH); M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

(Part 21 CFR 801 Subpart D)

Note 6: Small Organ: breast, thyroid, testes

X

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 5: 4D

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Indications For Use

Prescription Use

Macy S. Patel
(Division Sign-Off)

Office of aluation and Safety

510K KiizusT

3-13

20

Transducer: L742 Linear Array Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General
(TRACK 1
ONLY)	Specific
(TRACKS 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Other*
Combined	Other*
Specify
Ophthalmic	Ophthalmic
Fetal
Imaging&
Other	Fetal
	Abdominal
	Intra-operative Specify
	Intra-operative Neuro
	Laparoscopic
	Pediatric
	Small Organ (specify)	P	P	P		P	P	Note 1	Notes 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	Note 1	Notes 2, 4
	Musculo-skeletal
(Superficial)	P	P	P		P	P	Note 1	Notes 2, 4
	Intravascular
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2, 4
	Other (specify)

Note 1: Other Combined includes: BM; B/PW/J; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging.

Note 3: TDI Note 4: 3D

(Part 21 CFR 801 Subpart D)

Note 6: Small Organ: breast, thyroid, testes

X

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 5: 4D

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Indications For Use

Prescription Use

Mary S. Pfohl
(Division Sign-Off)

Division of Radiological Devices Office of In valuation and Safety

510K KUZUSI

3-14