DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K123185
• Device Name: DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
• Date Cleared: 2012-11-02 ( 23 days)
• Product Code: IYO ITX IYN
• Regulation Number: 892.1560

Intended Use

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, cardiac pediatric, peripheral vessel and urology exams.

Device Description

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 3D/4D mode, Elastography 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 3 MHz to 10.0 MHz.

Predicate Devices

K113647, K103583, K101041, K110199, K122010, K112596, K050034

Reference Devices

K113647, K103583, K101041, K110199, K122010, K112596, K050034

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" and its function is to "acquire and display ultrasound images," which points to a diagnostic rather than therapeutic purpose.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System". Additionally, the "Device Description" also refers to it as an "ultrasound diagnostic system".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "software controlled, ultrasound diagnostic system" and mentions employing "an array of probes," which are hardware components essential for acquiring ultrasound images.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. These tests are performed outside of the living body (in vitro).
• Device Description: The provided description clearly states that the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is an ultrasound diagnostic system. Ultrasound imaging uses sound waves to create images of internal body structures. This is a non-invasive imaging modality performed on the living body.
• Intended Use: The intended use describes various anatomical sites and patient populations for imaging exams. These are all procedures performed directly on the patient.

Therefore, based on the provided information, the device is a diagnostic imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, cardiac pediatric, peripheral vessel and urology exams.

Product codes

1YN, 1YO, ITX

Device Description

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 3D/4D mode, Elastography 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 3 MHz to 10.0 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology

Indicated Patient Age Range

adults, pregnant women, pediatric patients and neonates

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s)

K113647, K103583, K101041, K110199, K122010, K112596, K050034

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

510(K) SUMMARY

........ 3 | ................................................................................................................................................................. NOV

2 7.1112

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/23/85

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: [phone] Fax: [phone]

Contact Person:

Zhai Pei

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 28, 2012

2. Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic

Ultrasound System

Classification Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-1YN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Device Description:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 3D/4D mode,

1

Elastography 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 3 MHz to 10.0 MHz.

4. Intended Use:

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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, cardiac pediatric, peripheral vessel and urology exams.

5. Comparison with Predicate Devices:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

| Predicate

Device	Manufacturer	Model	510(k) Number
1	Mindray	DC-8/DC-8PRO/DC-8 CV
/DC-8 EXP/DC-8S	K113647
2	Mindray	DC-7	K103583
K101041
3	Mindray	DC-T6	K110199
4	Mindray	Z6	K122010
5	SIEMENS	ACUSON S2000	K112596
6	SIEMENS	SONOLINE Antares
Ultrasound Imaging
System	K050034

They have the similar technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices.

6. Non-clinical Tests:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC

2

60601-2-37, IEC 62304, IEC 62366,UL 60601-1, ISO14971, UD 2, UD 3 and ISO 10993-1.

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-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing health, science, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

MAR 2 1 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. l 2 Laboratory Drive Research Triangle Park, NC 27709

Re: K123185

Trade/Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO. IYN, and ITX Dated: September 27, 2012 Received: September 10, 2012

Dear Mr. Rongero:

This letter corrects our substantially equivalent letter of November 2, 2012.

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 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C5-2E	D8-3E
C7-3E	V11-3E
L12-3E	C11-3E
L14-6NE	DE10-3E
L14-6WE	V11-3BE
P4-2E	V11-3WE
D6-2E	L7-3E

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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 Ms. Lauren Hefner at [phone].

Sincerely Yours,

Narkin D'Ohm for

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

Enclosure(s)

5

Indications for Use

510(k) Number (if known):

Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

Indications For Use:

The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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-ട്ടിലെന്നും വാഹ്യമാന്ത്രി vessel and urology exams.

23185

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

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

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System:	DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
Transducer.	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track I Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1, 2,3, 4,6,7
	Abdominal.	P	P	P	P	P	P	P	Note 1, 2,3, 4,5,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,3, 4,5,6,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,6,7,8
Fetal Imaging &	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Other	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 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 (Conventional)	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, 2,4,5,6,7
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7
vessel	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.
	**Small organ-breast, thyroid, testes.
	***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
	Note8: Elastography
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Clinical Application			Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	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
	Intra-operative (Specify®)
	Intra-operative (Neuro)
	Laparoscopic
	Podiatric	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify®*)
	Fetal Imaging & Neonatal Cephalic
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	p	P	P		P	P	p	Note 1, 2, 4,6,7
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7
vessel	Other (Specify® ** )
	N=new indication; P=previously cleared by FDA:				Evadded under Appendix E
	Additional comments: Combined modes-BitM. PW+B、Color + B. Power + B. PW +Color+ B. Power + PW+B.
	· Intraoperative includes abdominal, thoracic, and vascular.
	** Small organ-breast, thyroid, testes.
*** Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: Sman3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
Note8: Elastography
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Concurrence of CDRH, Office of Device Evaluation(ODE)
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Thus
Clinical Application			Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	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
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify**)
Fetal Imaging &	Neonatal Cephalic
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7
vessel	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.
	**Small organ-breast, thyroid, testes.
	***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

Diagnostic Ultrasound Indications For Use Format

008-2

Office of In Vitro Diagnostics and Radiological Health

510(k) K123185

(Division Sign Off) Division of Radiological Health

ﻴﺔ

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DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System:

C5-2E Transducer:

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

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Hesith

彩 .

5100d K123185

008-3

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System:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

·Transducer: C7-3E

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

NoteS: TDI

Note6: Color M Note7: Biopsy Guidance

Note8: Elastography

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Michael D'Kunn
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Division of Radiological Health

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51000 K123185

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DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System:

LI2-3E Transducer:

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

Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (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, 4,6,7,8
Fetal Imaging &
Other	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 (Conventional)	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
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	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.
** Small organ-breast, thyroid, testes.
***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 Note8: Elastography

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Concurrence of CDRH, Office of Device Evaluation(ODE)

(Div n Sian

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

51004 K123185

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Transducer:	L14-6NE
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General (Track I Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
Fetal Imaging &
Other	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, 4,6,7,8
	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 (Conventional)	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
Cardiac	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	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.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System:

Note 2: Smart3D Note 3:4D(Real-time 3D) Note 4: iScape

NoteS: TDI

Note6: Color M Note7: Biopsy Guidance

Note8: Elastography

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

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

5100d K12318S

11

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System:

LI4-6WE Transducer:

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

Clinical Application		Mode of Operation
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (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, 4,6,7,8
Fetal Imaging &
Other	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 (Conventional)	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	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	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.
**Small organ-breast, thyroid, testes.
***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
Note8: Elastography
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Munhal D Dithm
(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

51000 K123185

12

	Clinical Application	Mode of Operation
General (Track
I Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6
	Small Organ (Specify**)
Fetal Imaging &	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,5,6
Other	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,5,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,4,5,6
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel
vessel	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.
	**Small organ-breast, thyroid, testes.
	***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

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Disgnostic Ultrasound System System:

P4-2E Transducer.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I

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Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Heath

K123185
: 5100d

008-8

.

13

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System: D6-2E

Transduccr:

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

Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note1,2, 3, 4,6
	Abdominal	P	P	P	P	P	P	P	Note1,2, 3, 4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note1,2, 3, 4,6
	Small Organ (Specify**)
	Fetal Imaging & Neonatal Cephalic
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	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.
**Small organ-breast, thyroid, testes.
***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

Note8: Elastography

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign Off)

Division of Radiotogical Health

Office of In Vitro Diagnostics and Radiotogical Health

51000 K123185

14

System: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

Transducer: D8-3E

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

Clinical Application		Mode of Operation
General (Track I Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note1, 2, 3, 4,6
	Abdominal	P	P	P		P	P	P	Note1, 2, 3, 4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note1, 2, 3, 4,6
	Small Organ (Specify**)
	Fetal Imaging & Neonatal Cephalic
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel
	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.

Additional comments: Combined modes=B+M; PW+B; Color + B; Power + B; PW+Color+ B; Power + PW + B:
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***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
Note 5: TDI
Note 6: Color M
Note 7: Biopsy Guidance

Note8: Elastography

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

.

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

51000 K123185

15

System: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

Transducer: D8-3E

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 (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1,2, 3, 4,6
	Abdominal	P	P	P		P	P	P	Note 1,2, 3, 4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2, 3, 4,6
	Small Organ (Specify**)
	Fetal Imaging & Neonatal Cephalic
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel
vessel	Other (Specify***)

Additional comments: Combined mod B+M.

*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***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

Note8: Elastography

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Richard D. Klem
(Division Sign Off)

Division of Radiological Health

Office of in Vitro Diagnostics and Radiological Health

51000 K123185

16

System: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System Transducer: VII-3E

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 (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal Imaging &
Other	Fetal	P	P	P		P	P	P	Note 1, 2, 4,6,7
		Abdominal
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (Specify**)
		Fetal Imaging & Neonatal Cephalic
	Other	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 (Conventional)
		Musculo-skeletal (Superficial)
		Intravascular
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheral	vessel	Peripheral vessel
		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.
		**Small organ-breast, thyroid, testes.
		***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
		Note8: Elastography
	Clinical Application	Mode of Operation
General
(Track I
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
	Ophthalmic Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N	Note 1, 2, 4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1, 2, 4,6
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic	N	N	N		N	N	N	Note 1, 2, 4,6
	Adult Cephalic
	Trans-rectal
	Trans-vagina)
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	N	N	N		N	N	N	Note 1, 2, 4,6
	Cardiac Pediatric	N	N	N		N	N	N	Note 1,2,4,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,4,6
	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.
	**Small organ=breast, thyroid, testes.
	***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
	Note8: Elastography
	Clinical Application			Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
	Ophthalmic Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1, 2, 3,4,6
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopie
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1, 2, 3,4,6
	Trans-vaginal	N	N	N		N	N	N	Note 1, 2, 3,4,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	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.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
	Note 2: SmartJD
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
	Ophthalmic Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1, 2, 4,6,
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
Fetal
Imaging &
Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1, 2, 4,6.
	Trans-vaginal	N	N	N		N	N	N	Note 1, 2, 4,6,
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)	N	N	N		N	N	N	Note 1, 2, 4,6,
	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.
	**Small organ-breast, thyroid, testes.
	***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
	Note8: Elastography

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

51000 K123185

17

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-5S Diagnostic Ultrasound System System: Transducer: CII-3E

Intended Use: Disgnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

(Divi

on Skai

vu

51000 K122185

18

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Disgnostic Ultrasound System System: Transducer: DE10-JE

Intended Use: Diagnostic Ultrasound imaging or fruid flow analysis of the human body as follows:

Concurrence of CDRII, Office of Device Evaluation(ODE)

Munhall D. Dihm
(Division Sign Off)

Division of Radiclogical Health

Office of In Vitro Diagnostics and Radiological Health

51000 K123185

19

DC-8DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Disgoostic Ultrasound System System: Transducer: VII-3BE

lmended Use: Disgnostic Ultrasound imaging or thuid flow analysis of the human body as follows:

(Division Sign Off)
Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

51006 K123185

008-14

.

20

	Clinical Application		Mode of Operation
General
(Track I
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
	Ophthalmic Ophthalmic
Fetal
Imaging &
Other	Fetal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (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	N	N	N		N	N	N	Note 1, 2, 4.6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify ***)	N	N	N		N	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. Power + B. PW+Color+ B. Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***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
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

System: DC-8DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System Transducer: VII-3WE

Intended Use: Disgnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

51000 K123185

21

DC-8DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System: Transducer: L7-JE

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the truman body as follows:

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (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
Fetal
Imaging &
Other	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 (Conventional)	N	N	N		N	N	N	Note 1,2, 4,6,7
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1,2, 4,6,7
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N		N	N	N	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.
	**Small organ-breast, thyroid, testes.
	***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
	Note8: Elastography

(Division Sign-Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(a) K123185