The DC-T6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric), peripheral vessel, urology and intraoperative (abdominal, thoracic, vascular) exams.

Device Description

DC-T6 Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, CW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 3D/4D 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 2.5 MHz to 10.0 MHz.

AI/ML Overview

The provided text is a 510(k) summary for the Mindray DC-T6 Diagnostic Ultrasound System. It details the device's classification, description, intended use, and comparison to predicate devices, along with non-clinical tests conducted. However, this document does not contain information about clinical acceptance criteria or a study that proves the device meets specific performance metrics.

The document does include "Diagnostic Ultrasound Indications for Use Form" for various transducers. These forms list the clinical applications for which each transducer is indicated (e.g., Fetal, Abdominal, Cardiac Adult) and the modes of operation available for those applications (e.g., B-Mode, M-Mode, Color Doppler). The 'P' next to many applications indicates "previously cleared by FDA," and 'N' indicates a "new indication." While this specifies what the device can be used for, it does not provide quantitative performance metrics or acceptance criteria for those uses, nor does it describe a study demonstrating such performance.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

Here's a breakdown of the specific points you requested and why the information isn't available:

A table of acceptance criteria and the reported device performance: This information is not present. The document lists "Indications for Use" but does not define acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance results from a clinical study.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. The document primarily focuses on regulatory classification and substantial equivalence to predicate devices, along with non-clinical tests (acoustic output, biocompatibility, electrical safety, etc.). No clinical study details (test set size, data provenance) are provided.
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 mentioned. As no clinical study is detailed, there's no information about ground truth establishment or the experts involved.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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 mentioned. The device is a "Diagnostic Ultrasound System," not explicitly an AI-assisted device, and no MRMC study is detailed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not mentioned.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

The document states that "DC-T6 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards." This refers to non-clinical technical evaluations rather than clinical performance studies against specific acceptance criteria. The clearance is based on substantial equivalence to predicate devices, implying that its performance is considered comparable to already approved devices without needing a new, extensive clinical performance study to establish new clinical performance criteria.

Summary

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

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: K/20699

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 8188 5658 Fax: +86 755 2658 2680

Contact Person:

Wu zicui

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: January 31th, 2012

2. Device Name:

DC-T6 Diagnostic Ultrasound System

Classification

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

3. Device Description:

B-1

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

Color M-Mode, Power/Dirpower Mode, TDI mode, 3D/4D 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 2.5 MHz to 10.0 MHz.

4. Intended Use:

5. Comparison with Predicate Device:

DC-T6 Diagnostic Ultrasound System is already cleared under premarket notification number K110199. The new feature is comparable with and substantially equivalent to the Mindray DC-7/ M7/ DC-8 Diagnostic Ultrasound System that are already cleared under premarket notification number K103583/K103677/ K113647 and Philips iU22 Diagnostic Ultraound System under premarket notification number K093563. They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.

6. Non-clinical Tests:

DC-T6 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, UD 3, 1EC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, UL 60601-1, ISO14971 and IEC 62304.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-T6 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, LLC 12 Laboratory Drive RESEARCH TRIANBLE PARK NC 27709

APR 1 9 2012

Re: K120699

Trade/Device Name: The DC-T6 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: April 5, 2012 Received: April 12, 2012

Dear Mr. Rongero:

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 I ins uttentimation of ourseand System, as described in your premarket notification:

	Transducer Model Number
3C5A	L11-4	P7-3
C5-2	L12-4	L14-6N
6C2	7L5	CB10-4
V10-4	L14-6	7LT4
V10-4B	P4-2	CW5s
L7-3	2P2
7L4A	4CD4

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

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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 Jeffrey Ballyns at (301) 796-6105.

Sincerely Yours,

1111111

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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

Indications for Use

510(k) Number (if known):

Device Name: The DC-T6 Diagnostic Ultrasound System

Indications for Use:

510K

The DC-T6 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, urology and intraoperative (abdominal, thoracic, vascular) exams.

Over - The - Counter Use Prescription Use X AND/OR (21 CFR Part 807 Subpart (21 CFR Part 801 Subpart D) C)

(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

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

System				Transducer		×
Model:			P4-2
510(k) Number(s)

					Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)TATURANDOEZKEINERI
antianaMusculo-skeletal Superficial
Intravascular
Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
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, PW +Color+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 3:4D(Real-time 3D)						------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Note 4: iScape						------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NoteS: TDI						. 11 September 19 March 2017 - 1 September 2017 - 1 Marie 2017 - 1 Marie 2017 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
Note6: Color M
Note7: Biopsy Guidance
(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)

Samual Morris
(Division/Sign-Off)

510K

(Division of Radiological Devices Office of in Vita of Haulotogical Device Evaluation and Safety

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

System		Transducer	X
Model:	L14-6
510(k) Number(s)

Diagnostic Ultrasound Indications for Use Form

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	Note 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	Note 1,2, 4,6,7
Small organ(specify)**	P	P	P	P	P	P	Note 1,2, 4,6,7
Neonatal Cephalic	P	P	P	P	P	P	Note 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph (non-Card.)
Musculo-skeletal	P	P	P	P	P	P	Note 1,2, 4,6,7
Musculo-skeletal Superficial	P	P	P	P	P	P	Note 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P	P		P	Note 1,2, 4,6,7
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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDBH. Office of Device Evaluation(ODE)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120699

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

Transducer

System Model:

DC-T6

510(k) Number(s)

Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	Note1,2, 3, 4,6,7
Abdominal	P	P	P	P	P	P	P	Note1,2, 3, 4,5,6,7
Intraoperative (specify)*	N	N	N		N	N	N	Note 1,2,4,6,7
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,5,6,7
Small organ(specify)**	P	P	P	P	P	P	P	Note1, 2, 4,6,7
Neonatal Cephalic	P	P	P	P	P	P	P	Note1, 2, 4,5,6,7
Adult Cephalic	P	P	P	P	P	P	P	Note1, 2, 4,5,6,7
Trans-rectal	P	P	P		P	P	P	Note 1,2,4,6,7
Trans-vaginal	P	P	P		P	P	P	Note 1,2,4,6,7
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal	P	P	P		P	P	P	Note 1,2,4,6,7
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2,4,6,7
Intravascular
Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,5,6,7
Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,5,6,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1,2,4,6,7
Other (specify)***	P	P	P		P	P	P	Note 1,2,4,6,7
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 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(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)

Janne Horris

(Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safs:

510K. K1206.99

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

System				Transducer	X
Model:	3C5A
510(k) Number(s)

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Abdominal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P	P	P	P	Note 1, 2, 4,6,7
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: 4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

(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)

Laune Morris
(Division Sign-Off)

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

610K.

5120699

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

Diagnostic Ultrasound Indications for Use Form

System
Model:	C5-2
510(k) Number(s)

Transducer	X
------------	---

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Abdominal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Superficial
Intravascular.
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P	P	P	P	Note 1, 2, 4,6,7
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 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance

(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)

Prescription 510-(K-12)

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K.

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

System
Transducer	X
Model:	6C2
510(k) Number(s)

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	Note 1, 2, 4,6,7
Small organ(specify) **
Neonatal Cephalic	P	P	P	P	P	P	Note 1, 2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Superficial
Intravascular
Cardiac Adult	P	P	P	P	P	P	Note 1, 2, 4,6,7
Cardiac Pediatric	P	P	P	P	P	P	Note 1, 2, 4,6,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P	P	P	P	Note 1, 2, 4,6,7
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: 4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

(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 Raciological Devices
Diffice of to Vitto Discion of Raciological Devices
Office of to Vitto Diegnostic Devices Evaluetion and Safety

610K Kia0699

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

System		Transducer	X
Model:	V10-4
510(k) Number(s)

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Trans-vaginal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric			4
Intravascular (Cardiac)
Trans-esoph (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	P	P	P	P	P	P	Note 1, 2, 4,6,7

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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

・

Prescription USE (Per 21 CFR 801.109)

Hause Hause
(Division Sign-Off)

Division of Rac ologics! Devices Office of the tion and Safety

RIOK

. .

the

008-6

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

System		Transducer	X
Model:	V10-4B
510(k) Number(s)

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Trans-vaginal	P	P	P	P	P	P	Note 1, 2, 4,6,7
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***	P	P	P	P	P	P	Note 1, 2, 4,6,7

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, 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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Hanne Thuris
(Division Sign-Off)
Division of Radiological Devices

Division of Radfological Devices Office of In Vitro Diegnostic Device Evaluation and Safety

510K.

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

System				Transducer		X
Model:			L7-3
510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 4,6,7
Small organ(specify) **	P	P	P		P	P	P	Note 1,2, 4,6,7
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1,2, 4,6,7
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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

(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)

Laurence Masters
(Division Sign-Off)

(Division of Badiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

810K

008-8

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

System				Transducer		×
Model:			7L4A
510(k) Number(s)

	Mode of Operation
Clinical Application	B	CombinedAmplitude	Other (specify)
		M	PWD	CWD	Doppler	Doppler	(specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 4,6,7
Small organ(specify) **	P	P	P		P	P	P	Note 1,2, 4,6,7
Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
TATUSQUID=2KCISIST	P	P	P		P	P	P	Note 1,2, 4,6,7
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1,2, 4,6,7
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, PW +Color+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 3:4D(Real-time 3D)
Note 4: iScape
NoteS: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription USE (Per 21 CFR 801.109)

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

510K. .

:" " "

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

{15}------------------------------------------------

System				Transducer		X
Model:			L11-4
510(k) Number(s)
					Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 4,6,7
Small organ(specify)**	P	P	P		P	P	P	Note 1,2, 4,6,7
Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletalConventional	P	P	P		P	P	P	Note 1,2, 4,6,7
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1,2, 4,6,7
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 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

Prescription USE (Per 21 CFR 801.109)

Hanne Rhene
(Division Sign-Off)

510K

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

{16}------------------------------------------------

System
Model:	L12-4
510(k) Number(s)

Diagnostic Ultrasound Indications for Use Form

Transducer	X
------------	---

Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 4,6,7
Small organ(specify) **	P	P	P		P	P	P	Note 1,2, 4,6,7
Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal	P	P	P		P	P	P	Note 1,2, 4,6,7
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular.	P	P	P		P	P	P	Note 1,2, 4,6,7
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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

(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 Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K-

008-11

、

{17}------------------------------------------------

						Diagnostic Ultrasound Indications for Use Form
System				Transducer		×
Model:			7L5
510(k) Number(s)

					Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	Doppler	Amplitude Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2, 4,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 4,6,7
Small organ(specify) **	P	P	P		P	P	P	Note 1,2, 4,6,7
Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Tamizatio_2KAIARI	P	P	P		P	P	p :	Note 1,2, 4,6,7
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2, 4,6,7
Intravascular

Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	D	P	P		P	P	P	Note 1,2, 4,6,7
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, 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 3:4D(Real-time 3D)
Note 4: iScape
NoteS: TDI
Note6: Color M

Note7: Biopsy Guidance

Prescription USE (Per 21 CFR 801.109)

: Divisio Affice of in Vitro tion and Safety . 510K

008-12

{18}------------------------------------------------

System Model:

Transducer . 2P2

510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletalConventional
Musculo-skeletal Superficial
Intravascular
Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
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 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

008-15

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109) *

(Division Sign-Off)

(Division of Radiological Devices
Office of in Vitro Diagnostic Devices
Office of in Vitro Diagnostic Devices Evaluation and Safety BIOK

{19}------------------------------------------------

Transducer

System Model:

4CD4

510(k) Number(s)

Mode of Operation Clinical Application Color Amplitude Combined CWD B M PWD Other (specify) Doppler Doppler (specify) Ophthalmic P Note1,2, 3, 4,6 Fetal P P P P P P P P Note1,2, 3, 4,6 Abdominal P P P Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic Pediatric Small organ(specify)** Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph.(non-Card.) MITH AND FILE 224 AM ANNI Musculo-skeletal Superficial Intravascular Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph.(Cardiac) Intra-Cardiac Peripheral Vascular 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, PW +Color+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 3:4D(Real-time 3D) Note 4: iScape Note5: TDI Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120699

{20}------------------------------------------------

P7-3

Transducer

System Model:

510(k) Number(s) .

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color		Amplitude Combined	Other (specify)
					Doppler	Doppler	(specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	N	Notel,2, 5,6
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	N	N	Notel ,2, 5,6
Small organ (specify) **
Neonatal Cephalic	N	N	N	N	. N	N	N	Notel 2, 5,6
Adult Cephalic	N	।	N.	N	N	N	N	Note 1,2, 5,6
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)MITSCHITO SKEARING
Musculo-skeletal Superficial
Intravascular
Cardiac Adult	N	N	N	N	N	ਨਿ	N	Note1,2,5,6
Cardiac Pediatric	N	N	N	N	N	N	પિ	Notel ,2, 5,6
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
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, PW+Color+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 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
		F TV	E	.	COLORIAL

Concurrence of CDRH, Office of Device Evaluation(ODE)

Preseription USE (Per 21 CFR 801.109)

(Division Sigh-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K.
K120699

008-17

{21}------------------------------------------------

System
Transducer	X
Model:	L14-6N
510(k) Number(s)

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	N	Note1,2, 4,6,7
Small organ(specify)**	N	N	N	N	N	N	Note1,2, 4,6,7
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal	N	N	N	N	N	N	Note1,2, 4,6,7
Musculo-skeletal Superficial	N	N	N	N	N	N	Note1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular	N	N	N	N	N	N	Note1,2, 4,6,7
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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

(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 Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120699

. .

Sales of the same

{22}------------------------------------------------

System				Transducer		×
Model:			CB10-4
510(k) Number(s)
					Mode of Operation
Clinical Application					. Color	Amplitude	Combined
	B	M	PWD	CWD	Doppler	Doppler	(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify) **
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N	N	N		N	N	N	Note 1, 2, 4,6,7
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card )MITRATIO - 21:41 AM
ratio
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify) ** *	પિ	N	N		હિં	N	N	Note 1, 2, 4,6,7
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+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 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance

Preseription USE (Per 21 CFR 801.109)

ANAKAN (Division SK Division of Radiological Devices Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety 810K-

008-19

{23}------------------------------------------------

System
Transducer	X
Model	7LT4
510(k) Number(s)

Diagnostic Ultrasound Indications for Use Form

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	Note 1,2, 4,6,7
Intraoperative (specify)*	N	N	N	N	N	N	Note 1,2, 4,6,7
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	N	Note 1,2, 4,6,7
Small organ(specify)**	N	N	N	N	N	N	Note 1,2, 4,6,7
Neonatal Cephalic	N	N	N	N	N	N	Note 1,2, 4,6,7
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal	N	N	N	N	N	N	Note 1,2, 4,6,7
Musculo-skeletal Superficial	N	N	N	N	N	N	Note1,2, 4,6,7
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	N	N	N	N	N	N	Note1,2, 4,6,7
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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Preseription USE (Per 21 CFR 801.109)

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

510K

008-20

{24}------------------------------------------------

System		Transducer	X
Model:	CW5s
510(k) Number(s)

Diagnostic Ultrasound Indications for Use Form

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric				N
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic				N
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal
Musculo-skeletal Superficial
Intravascular
Cardiac Adult				N
Cardiac Pediatric				N
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
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: 4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

(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)

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120699

008-21

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.