Esaote's Model 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the' following application: Abdominal. Musculo-skeletal. Urologic, and Vascular,

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Device Description

The 6100 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes.

The 6100 system has been cleared by FDA via K051837, K060827 and K081386.

The modified 6100, with respect to the cleared version 6100 via K051837, K060827 and K081386, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
b. New plastic housing of the system both to include the touch screen and to give a new style
c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
d. Software/Firmware modification to translate the touch screen information for the software: main software characteristics and performances have not been changed.

The 6200 is the model name of the modified 6100. The set of probes of the 6100 is exactly the same.

The 6200 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

AI/ML Overview

The provided text is a Special 510(k) Summary for the Esaote 6200 Ultrasound Imaging System. It describes modifications to an existing device (6100) and confirms that these modifications do not alter the intended use or fundamental scientific technology. The document focuses on demonstrating substantial equivalence to predicate devices and lists various clinical applications and operation modes for different transducers.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.

The tables within the document primarily indicate:

"P" (Previously cleared by FDA): This means the indication and mode of operation for a specific transducer were already approved based on prior submissions (K051837, K060827, K081386, or K091009). For these, new performance studies are generally not required to re-demonstrate safety and effectiveness unless the modification changes the fundamental scientific technology or intended use.
"N" (New indication): This indicates an indication not previously cleared for a specific transducer. For these, the applicant would typically provide data to support the new indication, but this data is not included in the provided text.
"E" (Added under Appendix): This also refers to expanded or new indications. Similar to "N," supporting data would be submitted, but it's not present here.

Therefore, I cannot fulfill your request for an acceptance criteria table and the details of a study proving the device meets those criteria, as this information is not present in the provided document. The 510(k) summary focuses on justifying substantial equivalence through a comparison of technological characteristics and intended uses rather than presenting new performance data for device modifications that are deemed not to significantly affect safety or effectiveness.

Summary

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

(10093)

Esaote, S.p.A.

JUN 2 5 2010

Special 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR1807.92(a).

807.92(a)(1)

Submitter Information

Esaote S.p.,A Via Siffredi 58 16153 Genova Italy

Contact Person:

Allison Scott 317.569.9500 x106 ascott@ansongroup.com

Date:

April 2, 2010

807.92(a)(2)

Trade Name:

6200 System

Common Name: Ultrasound Imaging System

Ultrasonic pulse Doppler imaging system 892.1550 Classification Name(s):

Ultrasonic pulsed echo imaging system 892.1560

90IYN; 90IYO Classification Number:

807.92(a)(3)

Predicate Device(s)

K051837, K060827, K081386

6100

Esaote, S.p.A.

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

Special 510(k) Summary 6200 System Esaole. S.p.A.

807.92 (a)(4)

Device Description

The 6100 system has been cleared by FDA via K051837, K060827 and K081386.

a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
b. New plastic housing of the system both to include the touch screen and to give a new style
c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
d. Software/Firmware modification to translate the touch screen information for the software: main software characteristics and performances have not been changed.

The 6200 is the model name of the modified 6100. The set of probes of the 6100 is exactly the same.

The 6200 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use(s)

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

Special 510ck) Summar 6 200 St stept I-saote. S.p. V

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

807.92(a)(6)

Technological Characteristics

The modifications reflected in this Special 510(k) for the 6200 are intended to improve the system's performance. The modifications have not altered the fundamental scientific technology or the intended use of the unmodified version of the 6100 cleared via K051837, K060827 and K081386.

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

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

' JUN 25 2010

EASOTE, S.P.A. % Ms. Allison Scott, RAC Regulatory Affairs Associate The Anson Group 11460 Meridian St., Ste 150 CARMEL IN 46032

Re: K100931

Trade/Device Name: 6200 Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 28, 2010 Received: June 1, 2010

Dear Ms. Scott:

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 6200 Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

PA230	C5-2 R13
PA240	CA123
PA122	CA430
PA023	CA431
LA332	CA541
LA435	CA631
LA522	2CW
LA523	5CW
LA923	HF CW

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

Page 2 - Ms. Scott

EC123	IOE323
EC1123	LP323
TRT33	BC431
TEE022	BL433
TEE132	BE1123

. 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/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics!Division of Postmarket Surveillance.

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

Sincerely yours,

Robert R. Be-ker/ (for)

Donald St. Pierre

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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

Indications for Use Statement

Model 6200 (Modified 6100)

Indications for Use

Special 510(k) Number (if known):

Device Name:

6200 Ultrasound Systems

Virtual Navigator can be used in the' following application: Abdominal. Musculo-skeletal. Urologic, and Vascular,

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Prescription Use X . . . (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Ralu R. Redberg Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510K K100931

Esaole, S.p.A.

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

6200 (modiffied 6100)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTi	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P		5, 6, 7, 8, 9
Total	P	P	P	P	P	P	P	P	P		5, 6, 7, 8, 9,12, 13, 15
Abdominal	P	P	P	P	P	P	P	P	P		5, 6, 8, 9,12, 13
Intraoperative (Abdominal)	P	P	P	P	P	P	P	P	P		5, 6, 7, 8, 9,12, 13
Intraoperative Neurological	P	P	P	P	P	P	P	P	P		5, 6, 7, 8, 9,12, 14
Pediatric	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Small Organ [1]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Conatal Cephalic	P	P	P	P	P	P	P	P	P		5, 6, 7, 8, 9,10, 11, 12
Adult Cephalic	P	P	P	P	P	P	P	P	P		5, 6, 7, 8, 9,10, 11, 12
Adult Cardiac	P	P	P	P	P	P	P	P	P		5, 6, 8, 9,10, 11, 12
Pediatric Cardiac	P	P	P	P	P	P	P	P	P		5, 6, 8, 9,12, 13, 14
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P
Transurethral	P	P	P	P	P	P	P	P	P
Intravascular	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P		5, 6, 8, 9,12, 13, 15
Laparoscopic	P	P	P	P	P	P	P	P	P		5, 6, 8, 9,12, 13
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9,12, 13, 14
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9,12, 13, 14
Other (Urological)	P	P	P	P	P	P	P	P	P		5, 6, 8, 12,13, 15
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTi	Other(specify)
Ophthalmic	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Fetal	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12, 15
Abdominal	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Small Organ [1]	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Adult Cardiac	P	P	P	P	P	P	P	P	P	P		6, 8, 9, 10, 11, 12
Pediatric Cardiac	P	P	P	P	P	P	P	P	P		6, 8, 9, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhancement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		P		5, 6, 8, 9
Abdominal		P	P	P	P	P	P		P		5, 6, 8, 9
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P		P		5, 6, 8, 9
Small Organ [1]		P	P	P	P	P	P		P		5, 6, 8, 9
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		P		5, 6, 8, 9
Adult Cardiac		P	P	P	P	P	P	P	P	P	5, 6, 8, 9
Pediatric Cardiac		P		P	P	P	P	P	P		5, 6, 8, 9

Transesophageal (Cardiac)Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P	P	P	P		P		5, 6, 8, 9
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTl	Other(specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Small Organ [1]
Neonatal Cephalic	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 10,11. 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12,15
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

Clinical Application	Mode of Operations							Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric			P		P	P	P		P		5, 6, 8, 9, 12
Small Organ [1]
Neonatal Cephalic			P		P	P	P		P		5, 6, 8, 9, 12
Adult Cephalic
Cardiac [2]			P		P	P	P		P		5, 6, 8, 9, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular			P		P	P	P		P		5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic	P	P	P	P	P	P	P				6, 8, 9, 12,
Rectal	P	P	P	P	P	P	P				6, 8, 9, 12,
Abdominal	P	P	P	P	P	P	P				6, 8, 9, 12,
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P				6, 8, 9, 12,
Small Organ [1]	P	P	P	P	P	P	P				6, 8, 9, 12, 13, 14
Neonatal Cephalic	P	P	P	P	P	P	P				6, 8, 9, 12,
Adult CephalicCardiac [2]	E	E	E	E	E	E	E		E		6, 8, 9, 10, 11, 12, 13
Transesophageal (Cardiac)Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P		P		6, 8, 9, 12, 13, 14
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P		6, 8, 9, 12, 13, 14
Other (Urological)	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P
Fetal	P	P	P	P	P	P	P	P	P		6, 8, 9, 12,
Abdominal	P	P	P	P	P	P	P	P	P		6, 8, 9, 12,
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P		6, 8, 9, 12,
Small Organ [1]	P	P	P	P	P	P	P	P	P		6, 8, 9, 12,
Neonatal Cephalic	P	P	P	P	P	P	P	P	P		6, 8, 9, 12, 14.13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P		6, 8, 9, 12, 13.15
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P		6, 8, 9, 12, 13, 14, 15
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P		6, 8, 9, 12, 13, 14, 15
Other (Urological)	P	P	P		P	P	P		P		6, 8, 9, 12,
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic	P	P	P		P	P	P
Fetal	P	P	P		P	P	P		P		6, 8, 9, 12,
Abdominal	P	P	P		P	P	P		P		6, 8, 9, 12,
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P		6, 8, 9, 12,
Small Organ [1]	P	P	P		P	P	P		P		6, 8, 9, 12,13
Neonatal Cephalic	P	P	P		P	P	P		P		6, 8, 9, 12,13, 14
Adult Cephalic											6, 8, 9, 12,
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P		6, 8, 9, 12,13, 15
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P		6, 8, 9, 12,13, 14, 15
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P		6, 8, 9, 12,13, 14, 15
Other (Urological)	P	P	P		P	P	P		P		6, 8, 9, 12,
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Fetal	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Abdominal	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Small Organ [1]	P	P	P	P	P	P	P		P		6, 8, 9, 12, 13, 14
Neonatal Cephalic	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Adult Cephalic
Cardiac [2]	E	E	E	E	E	E	E		E		6, 8, 9, 10, 11, 12, 13
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P		6, 8, 9, 12, 13, 15
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P		P		6, 8, 9, 12, 13, 14, 15
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P		6, 8, 9, 12, 13, 14, 15
Other (Urological)	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic	P	P	P	P	P	P	P	P
Fetal	P	P	P	P	P	P	P	P			6, 8, 9, 12,
Abdominal	P	P	P	P	P	P	P	P			6, 8, 9, 12,
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P			6, 8, 9, 12,
Small Organ [1]	P	P	P	P	P	P	P	P			6, 8, 9, 12,
Neonatal Cephalic	P	P	P	P	P	P	P	P			6, 8, 9, 12,
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P			6, 8, 9, 12,
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P	P			6, 8, 9, 12,13
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P			6, 8, 9, 12,13
Other (Urological)	P	P	P	P	P	P	P	P	P			6, 8, 9, 12,
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Fetal	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Abdominal	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Small-Organ [1]	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P		5, 6, 8, 9, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Other (Urological)	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TE!)	CnTI	Other (specify)
Ophthalmic	P	P	P	P	P	P	P				5, 6, 8, 9, 12
Fetal	P	P	P	P	P	P	P				5, 6, 8, 9, 12
Abdominal	P	P	P	P	P	P	P				5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Small Organ [1]	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Neonatal Cephalic	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P		P		5, 6, 8, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Other (Urological)
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Fetal	P	P	P	P	P	P	P		P		6, 8, 9, 12,15
Abdominal	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Small Organ [1}	P	P	P	P	P	P	P		P		5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P		P		5, 6, 8, 9,10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P		5, 6, 8, 9,12, 15
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P		P		5, 6, 8, 9,12, 15
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P		5, 6, 8, 9,12, 15
Other (Urological)	P	P	P	P	P	P	P		P		5, 6, 8, 9,12, 15

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Fetal	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15
Abdominal	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Small Organ [1]		P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 10,11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15
Other (Urological)	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 12
Fetal	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 12, 15
Abdominal	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 12
Small Organ [1]	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 12, 15
Laparoscopic
Musculo-skeletal Conventional [3]	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 12, 15
Musculo-skeletal Superficial [3]	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 12, 15
Other (Urological)	N	N	N	N	N	N	N	N	N	N	5, 6, 8, 9, 12, 15
Clinical Application	B	M	Mode of Operations				Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
			PWD	CWD	ColorDoppler	AmplitudeDoppler					Combined[4]
Ophthalmic	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Rectal	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15
Abdominal	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Small Organ [1]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 10,11..12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15
Other (Urological)	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12,15

N; New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast,
Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block-

் சம்பல்
இந்தியாக
இவர் திரைப்படம் |4] Combined modes are:
B+M+PW+CW+CFM+PD |5] CMM

6 100 Previously cleared via
K051837, K060827 and K081386

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

Office of In Vitro Diagnostic Device Evaluation
K160631
510K

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

6200 (Modified 6100) - PA230
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast,
Thyroid and Testicles

(9) XView
[10] Stress
[1] 1] Xstrain
[12] Xstrain
[12] Compound Imaging (Mview)
[15] Virtual Navigator [4] Combined modes are:
B+M+PW+CW+CFM+PD
[5] CMM
[6] 3D

To Sign-Official (Division Sign-Off)

ک రా

4100

210K

Previously cleared via K091009

Prescription Use Only Per 21 CFR 801 Part D Concurrence
of CDRH, Office of In Vitro Diagnostics (OIVD)

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

6200 (Modified 6100) - PA240
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast,
Thyroid and Testicles

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

ڪ 09 100 510K

Previously cleared via K091009

escription Use Only Per 21 CFR 801 Part D Concurrence
of CDRH, Office of In Vitro Diagnostics (OIVD)

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

6200 (Modified 6100) - PA122
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N; New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast
Thyroid and Testicles
[2] Cardiac is Adult and Pediatric

[4] Combined modes are:
B+M+PW+CW+CFM+PD

14 Granbinews Modes ATS:
(6) SMM
(6) 31) M
(6) STUM
(10) Stures)
(10) Stures (1) Novigator

Previously cleared via K091009

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and ce Evaluation and Safety
K10093

র্ড 1709 રાજ્યન

Prescription Use Only Per 21 CFR 801 Part D Conc
of CDRH Office of In Vitro Diagnostics (OIVE

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

6200 (Modified 6100) - PA023
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Vew indication; P: Previosuly cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast
Thyroid and Testicles
[2] Cardiac is Adult and Pediatric

[4] Combined modes are:
B+M+PW+CW+CFM+PD n i la la marka da kasar kasar kasar dan bara da kasar dan baran dan baran dan baran dan baran dan baran dan baran dan baran dan baran dan baran dan banyar dan banyar dan ban [5] СММ

reviously cleared via k09100

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

(Division Sign-Off)
Division of Radiological Devices
office of in Vitro Diagnostic Device Evaluation and Safe-

510K
K160231

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

6200 (Modified 6100) - LA332
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[2] Cardiac is Adult and Pediatric { } | Small Organs includes Breast
Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block

Sign of Raciological Devices Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evauation and Safety

1309

510K.

[14] Elastography

Previously cleared via K091009

escription Use Only Per 21 CFR 801 Part D Concu
of CDRH Office of In Vitro Diagnostics (QIVD)

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

6200 (Modified 6100) - LA435
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

N; New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast,
Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block-(4) Combined modes are:
B+M+PW+CFM+PD l6] 3Dan
[0] XTview
[3] XTViews
[13] Contribund Imaging
[13] TiP: Villew
[13] Virtual Navigator

(Division of Razliological Devices
Division of Raziological Devices

Port

ن جو

1000

210K

Previously cleared via K091009

Prescription Use Only Per 21 CFR 801 Part D Concurrence
of CDRH, Office of In Vitro Diagnostics (OIVD)

escription Use Only Per 21 CFR 801 Part D Concu
of CDRH Office of In Vitro Diagnostics (OIVD)

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

6200 (Modified 6100) - LA522
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[2] Cardiac is Adult and Pediatric [1] Small Organs includes Breast
Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block [4] Combined modes are:
B+M+PW+CFM+PD [0] XView
[12] Compound Imaging
[13] Tompound Imaging
[13] Vir-Viral Navigator
[114] Vilasural Navigator
[15] Virtual Navigator [6] 3D
[8] VPan

Previously cleared via K091009

7
(Division Sign-Off
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K 5100931

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

6200 (Modified 6100) - LA523

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

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

New indication; P: Previosuly cleared by FDA; E:Added under Appendix N:

|1| Small Organs includes Breas
Thyroid and Testicles
[2] Cardiac is Adult and Pediatri

Cardiac is Adult and Pediat.

|3| Musculo Skeletal - Nerve Block
[4] Combined modes are:
B+M+PW+CFM+PD

... *.

ﮐﮯ

CSG ()

510K.

(Division of Radiological Devioles)
Division of Radiological Device Evalication and Safety

Previously cleared via K091009

escription Use Only Per 21 CFR 801 Part D Concurrence
of CDRH, Office of In Vitro Diagnostics (OIVD)

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

6200 (Modified 6100) - LA923
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

New indication; P: Previosuly cleared by FDA; E:Added under Appendix N

{ l | Small Organs includes Breast
Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block [4] Combined modes are:
B+M+PW+CFM+PD [9] XView
[12] Compound Imaging
[13] TP-View [6] 3D
[8] VPan

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

ਾ

510K

Previously cleared via K091009

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

6200 (Modified 6100) - C5-2 R13

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

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

New indication; P: Previosuly cleared by FDA; E:Added under Appendix N:

[1] Small Organs includes Breast,
Thyroid and Testicles
[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block
[4] Combined modes are:
B+M+PW+CFM+PD [10] Stress
[11] Xstrain
[12] Compound Imaging !
[8] VPan
[9] XView [5] CMM (6) 3D

510K

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

Previously cleared via K091009

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

6200 (Modified 6100) - CA123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

|2| Cardiac is Adult and Pediatric [1] Small Organs includes Breast
Thyroid and Testicles

[3] Musculo Skeleta] - Nerve Block-

Division Sign-Official Sign-Official Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Device of In Vitro Diagnostic Devices Evaluationand S

ﮐﺎ

000

510K

్. స్త్రీ

[4] Combined modes are:
B+M+PW+CFM+PD ls) CMM
(6) VDan
(8) XV) XVilesu
(10) Stureas
112) Compound Imaging Previously cleared via K091009

Prescription Use Only Per 21 CFR 801 Part D Concur
of CDBH Office of In Vitro Diagnostics (OIVD)

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

6200 (Modified 6100) - CA430

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast,
Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3| Musculo Skeletal - Nerve Block iai SDan
(6) Xtricuss
(8) Streetin
(1) || Xstreain
118) Vienual Navigator [4] Combined modes are:
B+M+PW+CFM+PD
[5] CMM

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

رک of

રાજ્ય

Previously cleared via K091009

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

6200 (Modified 6100) - CA431
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

New indication; P: Previosuly cleared by FDA; E:Added under Appendi

[1] Small Organs includes Breast,
Thyroid and Testicles
[2] Cardiac is Adult and Pediatric

3] Musculo Skeietal - Nerve Block

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

ದ 09

10 (

510K.

Previously cleared via K091009

Prescription Use Only Per 21 CFR 801 Part D Concurrence
of CDRH, Office of In Vitro Diagnostics (OIVD)

escription Use Only Per 21 CFR 801 Part D Concurre
of CDRH Office of In Vitro Diagnostics (OVD)

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

6200 (Modiffed 6100) - CA.541
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast,
Thyroid and Testicles
[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block |6| GMM
|6| VPan
|0| Nikologia
|0| Nikosas
|11.1| Xiaoraio
|13| Virtual Navigator [4] Combined modes are
B+M+PW+CFM+PD

510K

(Division of Radiological Devices) Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Satety

To be cleared via this submission

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

6200 (Modified 6100) - CA631
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendi

[2] Cardiac is Adult and Pediatric [1] Small Organs includes Breast
Thyroid and Testicles

[3] Musculo Skeletal - Nerve Block [10] Stress
[11] Xstrain
[12] Compound Imaging
[15] Virtual Navigator [4] Combined modes are:
B+M+PW+CFM+PD [6] 3D
[8] VPan
[9] XView [5] CMM

(Division Sign-Off)

10093

510K

Previously cleared via K091009

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

6200 (Modified 6100) – 2CW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]				P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

New indication; P: Previosuly cleared by FDA; E:Added under Appendix E
result Previosuly cleared by FDA; E: C ﺧ

DA; E:Added under Appendix E

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

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and S

ત્ત

[4] Combined modes are: CW

[2] Cardiac is Adult and Pediatri

Previously cleared via K091009

1009 510K escription Use Only Per 21 CFR 801 Part D Concurrence
of CDRH, Office of In Vitro Diagnostics (OIVD)

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

c200 (Modified "Ideal" 100) - ECMWF

6200 (Modified 6100) – 5CW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

Previously cleared via K091009

Prescription Use Only Per 21 CFR 801 Part D Concurrence

510K
K1600931
Office of In Vitro Diagnostic Device Evaluation and Saf

(Division Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation a

[4] Combined modes are: CW

Previously cleared via KO.

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

$2000 Modified-FFI (100%-Efficient)

6200 (Modified 6100) - HF CW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				N
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[4] Combined modes are: CW

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K: K100931
410093 510K -------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use Only Per 21 CFR 801 Part D Concurrence

510K
16653

To be cleared via this submission

{25}------------------------------------------------

C200(1000)-Modified-ECC123
(6100)

6200 (Modified 6100) - EC123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic	P	P	P		P				P		6, 8, 9, 12
Fetal		P	P		P	P	P
Abdominal							P
Intraoperative (Abdominal)						P
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal		P	P		P	P	P		P		6, 8, 9, 12
Transvaginal		P	P	P		P	P	P			6, 8, 9, 12
Transurethral		P	P	P		P	P	P
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)		P	P	P	P	P	P	P		P		6, 8, 9, 12, 15
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic		P
Fetal			P		P		P		P		5, 6, 8, 9, 12
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal		P	P		P	P	P				5, 6, 8, 9, 12, 14
Transvaginal		P	P		P	P	P		P		5, 6, 8, 9, 12
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)		P	P	P	P	P	P		P		5, 6, 8, 9, 12

Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic		E	E		E	E	E		E		6, 8, 9, 12,
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal		P	P		P				P		6, 8, 9, 12,13, 14
Transvaginal		P	P		P	P	P		P		6, 8, 9, 12,13, 14
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)		P	P		P	P	P		P		6, 8, 9, 12,
Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]											5, 6, 9, 10,
Transesophageal (Cardiac)	P	P	P	P	P	P	P		P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]											5, 6, 9, 10,
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTi	Other (specify)
Ophthalmic	P	P	P	P	P	P	P
Fetal	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Abdominal	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Intraoperative (Abdominal)
Intraoperative Neurological											6, 8, 9, 12,
Pediatric	P	P	P	P	P	P	P		P
Small Organ [1]	P	P	P	P	P	P	P		P		6, 8, 9, 12, 13, 14
Neonatal Cephalic	P	P	P	P	P	P	P		P		6, 8, 9, 12,
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P		P	P	P		P		6, 8, 9, 12,
Laparoscopic											6, 8, 9, 12,
Musculo-skeletal Conventional [3]		P	P		P	P	P		P		6, 8, 9, 12, 13
Musculo-skeletal Superficial [3]		P	P		P	P	P		P		6, 8, 9, 12, 13
Other (Urological)		P	P		P	P	P		P		6, 8, 9, 12,
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined [4]	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic
Fetal	P	P	P		P		P		P		5, 6, 8, 12,
Abdominal	P	P	P		P	P	P		P		5, 6, 8, 12,
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P		5, 6, 8, 12,
Small Organ [1]	P	P	P		P	P	P		P		5, 6, 8, 12,
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P		5, 6, 8, 12,
Laparoscopic	P	P	P		P	P	P		P		5, 6, 8, 12,
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (4)	Color Velocity Mapping (TVM)	Tissue Enhacement Imaging (TEI)	CnTI	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P		5, 6, 7, 8, 9,
Fetal	P	P	P	P	P	P	P	P	P		5, 6, 7, 8, 9,
Abdominal	P	P	P	P	P	P	P	P	P
Intraoperative (Abdominal)
Intraoperative Neurological		E	P	E	E	E	E				5, 6, 7, 8, 9,
Pediatric	P	E	P	E	E	E	E				5, 6, 8, 9, 12
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P		5, 6, 7, 8, 9,10, 11, 12
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P		5, 6, 8, 9, 12
Laparoscopic
Musculo-skeletal Conventional [3]											5, 6, 8, 9, 12
Musculo-skeletal Superficial [3]											5, 6, 8, 9, 12
Other (Urological)	P	P	P	P	P	P	P	P	P		6, 6, 8, 9, 12
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic	P	P	P	P	P	P	P
Fetal	P	P	P	P	P	P	P				6, 7, 8, 9, 12,13
Abdominal	P	P	P	P	P	P	P				6, 7, 8, 9, 12,13
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P				6, 7, 8, 9, 12,13
Small Organ [1]	P	P	P	P	P	P	P				6, 7, 8, 9, 12,13
Neonatal Cephalic	P	P	P	P	P	P	P				6, 8, 9, 12,13
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P		6, 8, 9, 12,13
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P		P		6, 8, 9, 12,13
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P		6, 8, 9, 12,13
Other (Urological)	P	*	P	P	P	P	P		P		6, 8, 9, 12,
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[4]	Color VelocityMapping (TVM)	Tissue EnhacementImaging (TEI)	CnTI	Other(specify)
Ophthalmic	P	P	P		P
Fetal	P	P	P		P	P	P		P		5, 6, 7, 9, 12
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P		P		5, 6, 8, 9, 12
Transvaginal	P	P	P		P	P	P		P		5, 6, 8, 9, 12
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P		5, 6, 9, 12

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[4] Combined modes are:
B+M+PW+CFM+PD (6) 3D
[8] VPan
[9] XView
[12] Compound Imaging
[12] Compound Navigator [5] CMM

Previously cleared via K091009

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

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

510K
K10609 13

{26}------------------------------------------------

6200 (Modified 6100) - EC1123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[4] Combined modes are:
B+M+PW+CFM+PD [6] VPan
[8] VFan
[9] XView
[12] Compound Imaging
[14] Elastography [5] CMM

Previously cleared via K091009

Description Use Only Per 21 CFR 801 Part D Compliance

JES IN AS COLLECON SECON SECTION

ಗ 0

100

510K

{27}------------------------------------------------

6200 (Modified 6100) - TRT33
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

(6) 3D
(8) XPsew
(9) XPsew
(13) Krompound Imaging
(13) TB-View
(14) Elastography (4) Combined modes
are:B+M+PW+CFM+PD
[5] CMM

Previously cleared via K091009

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

510K K100931

scription Use Only Per 21 CFR 801 Part D Concurrence
of CDRH, Office of In Vitro Diagnostics (OIVD)

{28}------------------------------------------------

6200 (Modified 6100) - TEE022

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[4] Combined modes are:
B+M+PW+CW+CFM+PD
[5] CMM
[6] 3D [9] XView
{10} Stress
[11] Xstrain

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

ري 1009 510K-

Previously cleared via K091009

rescription Use Only Per 21 CFR 801 Part D Concurrence
of CDRH, Office of In Vitro Diagnostics (OIVD)

{29}------------------------------------------------

6200 (Modified 6100) - TEE132
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[4] Combined modes are:
B+M+PW+CW+CFM+PD [9] XView
[10] Stress
[11] Xstrain [5] CMM
[6] 3D

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

(Division Sign-Off)
Division of Radiological Devices/
ffice of In Vitro Diagnostic Device Evaluation and S.

Office of In Vitro Diagnostic Device Evaluation ar
6160931

ਟ

Office Of In Vitro Diagnostic Device Evaluation
510K K160931/

Previously cleared via K091009

Prescription Use Only Per 21 CFR
nICCRH Office of In Vitro

{30}------------------------------------------------

6200 (Modified 6100) - IOE323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

New indication; P: Previosuly cleared by FDA; E:Added under Appendix ら

|1| Small Organs includes Breast
Thyroid and Testicles

[3] Musculo Skelctal - Nerve Block
[4] Combined modes arc:
B+M+PW+CFM+PD (6) VPan
(8) VPan
(8) XV Vibropound Imaging
(113) Tip-View
(114) Elastography

This (Division Sign-Off)

(3099

510K

[14] Elastography

Previously cleared via K091009

{31}------------------------------------------------

6200 (Modified 6100) - LP323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[I] Small Organs includes Breast
Thyroid and Testicles [4] Combined modes are:
B+M+PW+CW+CFM+PD (6) 3D
[8] VPan
[9] XView
[12] Compound Imaging
[13] TP-View

Clinision Sign-Off
Division of Radiological Devices
Vitro Diagnostic Devices Devices
Vitro Diagnostic Device Evaluation and Satety 00

Office of In 1

్లో

510K.

Previously cleared via k09100

Prescription Use Only Per 21 CFR 801 Part D Concurrence
of CDRH, Office of In Vitro Diagnostics (OIVD)

{32}------------------------------------------------

6200 (Modified 6100) - BC431

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[2] Cardiac is Adult and Pediatric [1] Small Organs includes Breast
Thyroid and Testicles

(3) Museumo Sikeletal - Nerve Bloek
(8) Kombined med med med Blood
(8) Storial (6) Albani (8)
(8) Status (2008) - 1) (2008) 1988 (2007) - 1998 (2008) (2008) 1988 (2007)

(Division Sign-Off Raciological Devices
Division of Raciological Devices Devices
Office of In Vitro Diagnostic Devices Devices

093

510K

Previously cleared via K091009

Prescription Use Only Per 21 CFR 801 Part D Concur
of CDRH, Office of In Vitro Diagnostics (OIVD)

{33}------------------------------------------------

6200 (Modified 6100) - BL433
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

(2) Cardiac is Adult and Pediatric [1] Small Organs includes Breast
Thyroid and Testicles

[3] Musculo Skelctal - Nerve Block
[4] Combined modes are:
B+M+PW+CFM+PD [6] 3D
[7] 4D
[9] XView
[12] Compound Imaging
[13] TP-View

(Division Sign-Off) (Division Sign-Off)
Division of In Viro Diagnostic Devices
Office of In Viro Diagnostic Devices
And Satery Chagnostic Device Evauation and Satery

510K

Previously cleared via K091009

{34}------------------------------------------------

S200(Modified Lead S100) - BE11123

6200 (Modified 6100) - BE1123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix

[4] Combined modes are:
B+M+PW+CFM+PD [9] XView
[12] Compound Imaging (5) CMM [6] 3D

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

510K

Previously cleared via K091009

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.