The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, intraoperative (abdominal, thoracic, and vascular etc.), pediatric, neonatal cephalic, musculoskeletal (general and superficial).

Device Description

The M5 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

AI/ML Overview

The provided text describes a 510(k) Pre-Market Notification for the KOS-3001 M5 Diagnostic Ultrasound System. It asserts substantial equivalence to predicate devices and describes the intended use and safety considerations. However, it does not contain any information regarding acceptance criteria or a specific study proving the device meets those criteria.

The document mainly focuses on:

Device Identification: Name, submitter, date prepared.
Classification: Regulatory class, review category, product codes.
Marketed Devices: Listing predicate devices for substantial equivalence.
Device Description: General description, modes of operation, probe types, and frequency range.
Intended Use: Clinical applications for which the device is intended.
Safety Considerations: Compliance with FDA guidance and medical device safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, etc.).
FDA Clearance Letter: Formal letter from the FDA stating substantial equivalence and listing cleared transducers and their clinical applications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving these criteria are met, as this information is not present in the provided text.

To answer your specific questions in the context of this document:

A table of acceptance criteria and the reported device performance: Not available in the provided text. The document asserts safety and effectiveness through compliance with standards and substantial equivalence to predicate devices, but no specific performance criteria or results are listed.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available in the provided text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available in the provided text. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as there is no mention of an algorithm for standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in the provided text.
The sample size for the training set: Not applicable as there is no mention of a training set for an AI algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

KOS-3001

OCT 2 2 2008

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(c).

The assigned 510(k) number is: _ _ _ _ _ _ _ _ _ _ _ _

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: +86 755 2658 2888 Fax: +86 755 2658 2680

Contact Person: Li Dongling Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: August 31, 2008

2. Device Name: M5 Diagnostic Ultrasound System

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 (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Marketed Device:

The subject device is substantially equivalent in its technologies and functionality to the original M5 Diagnostic Ultrasound System that is already cleared under premarket notification number K080640, and the other predicate devices are listed below: Mindray DC-6 (K072164), GE logiq 9 (K061129), GE Logiq E (K072797), Mindray DP-6600 (K060949), Philips IU22 (K042540).

{1}------------------------------------------------

4. Device Description:

5. Intended Use:

6. Safety Considerations:

The M5 Diagnostic Ultrasound System 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 in September 1997. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Output Display Standard. 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 and ISO 10993-1.

Conclusion:

The conclusions drawn from testing of the M5 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2008

Shenzhen Mindray Bio- Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President CITECH Medical Device Testing and Consulting 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K083001

Trade/Device Name: M5 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 7, 2008 Received: October 8, 2008

Dear Mr. Mosenkis:

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 M5 Diagnostic Ultrasound System, as described in your premarket notification:

3C5s
6C2s
6CV1s
7L4s, 7L6s, 10L4s
6LE7s
6LB7s

Transducer Model Number

{3}------------------------------------------------

3C1s
2P2s
7L5s
7LT4s

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 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 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 (QS) 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 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain 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 (240) 276-3150 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 Mr. Paul Hardy at (240) 276-3666.

Sincerely yours,

Joyce M. Whang, Ph.D.

ce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{4}------------------------------------------------

K082001 VOL

Mindray Co. Ltd.- M5 Diagnostic Ultrasound System

Diagnostic Ultrasound Indications for Use Form System × Transducer Model: Mર 510(k) Number(s) KOS3001

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal		P	P	P		P	P		P	Note 1, 2, 3, 4
Abdominal		P	P	P	N	P	P		P	Note 1, 2, 3, 4
Intraoperative (specify)*		N	N	N		N	N		N	Note 2, 3, 4
Intraoperative Neurological
Pediatric		P	P	P	N	P	P		P	Note 1, 2, 3, 4
Small organ(specify)**		P	P	P		P	P		P	Note 2, 3, 4
Neonatal Cephalic		P	P	P	N	P	P		P	Note 1, 2, 3, 4
Adult Cephalic		P	P	P	N	P	P		P	Note 1, 2, 3
Cardiac		P	P	P	N	P	P		P	Note 1, 2, 3
Transesophageal
Transrectal		P	P	P		P	P		P	Note 2, 3, 4
Transvaginal		P	P	P		P	P		P	Note 2, 3
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		P	Note 1, 2, 3, 4
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P		P	Note 2, 3, 4
Musculo-skeletal Superficial		P	P	P		P	P		P	Note 2, 3, 4
Other (specify) ***		P	P	P		P	P		P	Note1, 2, 3, 4
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology/Prostate.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: iBeam

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Per 21 CFR 801.109)

(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev

510(k) Number

{5}------------------------------------------------

System					Transducer	X
Model:			3C5s
510(k) Number(s)

Clinical Application	B	M	PW D	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	Note 1, 2, 3
Abdominal	P	P	P	P	P	P	Note 1, 2, 3
Intraoperative (specify)*
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	Note 1, 2, 3
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	Note 1, 2, 3
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)***	N	N	N	N	N	N	Note 1, 2, 3

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

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note 4: iBeam

Diagnostic Ultrasound Indications for Use Form

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Rel 21 CFR 801.109)

(Division Sign-Off)

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

0066 ·

{6}------------------------------------------------

System		Transducer	X
Model:	6C2s
510(k) Number(s)

Mode of Operation

Clinical Application	B	M	PW D	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	Note 2, 3
Intraoperative (specify)*
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	Note 2, 3
Small organ(specify)**
Neonatal Cephalic	P	P	P	P	P	P	Note 2, 3
Adult Cephalic	P	P	P	P	P	P	Note 2, 3
Cardiac	P	P	P	P	P	P	Note 2, 3
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)***	N	N	N	N	N	N	Note 2, 3

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

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note 4: iBeam

Diagnostic Ultrasound Indications for Use Form

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

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

{7}------------------------------------------------

System		Transducer	X
Model:	6CV1s
510(k) Number(s)

Clinical Application	B	M	PW D	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	Note 2, 3
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P	Note 2, 3
Transvaginal	P	P	P	P	P	P	Note 2, 3
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify) ***	P	P	P	P	P	P	Note 2, 3

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

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc.

*** Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note 4: iBeam

Diagnostic Ultrasound Indications for Use Form

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abd and Radiological Devic

510(k) Number

{8}------------------------------------------------

System		Transducer	X
Model:	7L4s, 7L6s, 10L4s
510(k) Number(s)

Clinical Application	A	B	M	PW D	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	N	Note 2, 3, 4
Intraoperative (specify)*
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N	Note 2, 3, 4
Small organ(specify)**		P	P	P	P	P	P	Note 2, 3, 4
Neonatal Cephalic		P	P	P	P	P	P	Note 2, 3, 4
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P	P	P	P	Note 2, 3, 4
Laparoscopic
Musculo-skeletal Conventional		P	P	P	P	P	P	Note 2, 3, 4
Musculo-skeletal Superficial		P	P	P	P	P	P	Note 2, 3, 4
Other (specify)***

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

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note 4: iBeam

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

Diagnostic Ultrasound Indications for Use Form

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Dev

510(k) Number K0836

{9}------------------------------------------------

System

Model:		6LE7s
510(k) Number(s)
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal		P	P	P		P	P		P	Note 2, 3, 4
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		P	Note 2, 3, 4
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)***		P	P	P		P	P		P	Note2, 3, 4
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: iBeam

Diagnostic Ultrasound Indications for Use Form ×

Transducer

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

{10}------------------------------------------------

System	Transducer X
Model:	6LB7s
510(k) Number(s)

Mode of Operation

Clinical Application	B	M	PW D	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P	Note 2,3,4
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify) ***	P	P	P	P	P	P	Note 2,3,4

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

Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology/Prostate.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note 4: iBeam

Diagnostic Ultrasound Indications for Use Form

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

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.

{11}------------------------------------------------

Clinical Application	B	M	PW D	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	Note 1, 2, 3
Intraoperative (specify)*
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	Note 1, 2, 3
Small organ (specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	Note 1, 2, 3
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)***

Diagnostic Ultrasound Indications for Use Form

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

Prescription USE (Per 21 CFR 801.109)

Hubert Lehman

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

{12}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Transducer × System Model: 282s 510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N		N	Note 1, 2
Intraoperative (specify)*
Intraoperative Neurological
Pediatric		N	N	N	N	N	N		N	Note 1, 2
Small organ(specify) **
Neonatal Cephalic		N	N	N	N	N	N		N	Note 1, 2
Adult Cephalic		N	N	N	N	N	N		N	Note 1, 2
Cardiac		N	N	N	N	N	N		N	Note 1, 2
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify) ***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape

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

Prescription USE (Per 21 CFR 801.109)

Hulu Leim

Division of Reproductive, Abdomina and Radiological Device 510(k) Number.

{13}------------------------------------------------

・

System					Transducer	X
Model:			7L5s
510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N		N	N		N	Note 2, 3, 4
Intraoperative (specify)*
Intraoperative Neurological
Pediatric	N	N	N	N		N	N		N	Note 2, 3, 4
Small organ(specify)**	N	N	N	N		N	N		N	Note 2, 3, 4
Neonatal Cephalic	N	N	N	N		N	N		N	Note 2, 3, 4
Adult Cephalic
Cardiac
Transesophagea!
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N		N	N		N	Note 2, 3, 4
Laparoscopic
Musculo-skeletal Conventional	N	N	N	N		N	N		N	Note 2, 3, 4
Musculo-skeletal Superficial	N	N	N	N		N	N		N	Note 2, 3, 4
Other (specify)***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
Note 4: iBeam

Diagnostic Ultrasound Indications for Use Form

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

Prescription USE (Per 21 CFR 801.109)

Hubert Lemm

Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K083001

{14}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

7LT4s

Transducer X

510(k) Number(s)

System Model:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N	Note 2, 3, 4
Intraoperative (specify)*		N	N	N		N	N		N	Note 2, 3, 4
Intraoperative Neurological
Pediatric		N	N	N		N	N		N	Note 2, 3, 4
Small organ(specify)**		N	N	N		N	N		N	Note 2, 3, 4
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N		N	Note 2, 3, 4
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N	Note 2, 3, 4
Laparoscopic
Musculo-skeletal Conventional		N	N	N		N	N		N	Note 2, 3, 4
Musculo-skeletal Superficial		N	N	N		N	N		N	Note 2, 3, 4
Other (specify) ***
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.

***Other use includes Urology. Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D Note 3: iScape Note 4: iBeam

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

Prescription USE (Per 21 CFR 801.109)

Signature

Off Reproductive, Abdomin and Radiological Dev

510(k) Number K083001

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.