Esaote's MyLab90 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.

Device Description

The 6100 MyLab 90 is a mainframe ultrasound system used to perform diagnostic The 0100 MfLad 70 15 a manning modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The 6100 is equipped with a CRT Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations.

The 6100 can drive phased (PA), convex (CA), linear array (LA) and Doppler probes.

The 6100 is equipped with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional Data can also be berear and of the 6100 include an S-VHS video recorder; a accessory - devices - a rease printer. The 6100 is equipped with an isolation transformer to adequately insulate the system's peripherals.

AI/ML Overview

The provided 510(k) summary for the MyLab90 Ultrasound Imaging System does not contain information on specific acceptance criteria for performance metrics, nor does it detail a study that explicitly proves the device meets such criteria in terms of clinical efficacy or diagnostic accuracy. Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and indications for use.

The data provided primarily outlines:

The device's technical characteristics and modes of operation.
Its intended uses across various clinical applications.
A comparison of the MyLab90 features with several predicate devices.
A list of compatible transducers.
Regulatory information, including the FDA's "substantial equivalence" determination.

There is no mention of:

Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy).
A test set size, data provenance, or details on ground truth establishment for performance evaluation.
The number or qualifications of experts used for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
Standalone (algorithm-only) performance studies.
Sample sizes for training sets or how ground truth for training was established.

The "study" implicitly proving the device meets acceptance criteria is the comparison and demonstration of substantial equivalence to already cleared predicate devices, as detailed in the technical specifications comparison table. This is a common method for 510(k) clearance, where a new device is shown to be as safe and effective as an existing legally marketed device without necessarily conducting new clinical trials for efficacy.

Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, explicit performance acceptance criteria and reported metrics in the traditional sense (e.g., sensitivity, specificity) are not available. The "performance" described relates to functional capabilities and equivalence to predicate devices. The table below summarizes the key comparative information from the document.

Acceptance Criterion (Implicit)	Reported Device Performance (MyLab90)
Modes of Operation (equivalence to predicate devices)	Supported: 2D, M-Mode, PW, CW, CFM, Amplitude Doppler (PD), TEI (Tissue Enhancement Imaging), CnTI (Contrast Media), 3D, VPan, TVM (Tissue Velocity Mapping), Compound Imaging, Bi-Scan. Similar to or exceeding modes offered by predicate devices (Technos, MyLab 50, Megas, iU22). Some modes like Bi-Scan and Intelligent Real-Time Image Processing are new compared to older Esaote predicates.
Clinical Indications for Use (equivalence to predicate devices)	Supported: Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (conventional and superficial), Abdominal, Fetal, Transvaginal, Transrectal, Adult Cephalic, Pediatric, Laparoscopic, Intraoperative: Abdominal, Urologic. Largely equivalent or expanded compared to predicate devices. Specific 'N' (new indications) are noted for various transducers/applications.
Imaging Frequencies (within established range)	1 - 16 MHz (comparable to Technos: 1.5 - 16 MHz; broader than MyLab 50 and Megas: 2 - 10 MHz)
CFM/Doppler Frequencies (within established range)	2 - 12 MHz (comparable to Technos: 2 - 12 MHz; broader than MyLab 50: 2 - 8 MHz, and Megas: 2 - 5 MHz)
Electrical Safety/Ultrasound Safety	Complies with IEC60601-1 and Track 3 (Acoustic Output Display). This implies meeting relevant safety standards.
Probe Technology (supported types)	Phased Array, Convex Array, Linear Array, Doppler probes, compatible with specific listed transducer models.
Digital Archival Capabilities	YES (including DVD-RW and LAN for image storage).
DICOM Classes	Media Storage, Storage SCU.

Details of the "Study" (Substantial Equivalence Demonstration):

Sample size used for the test set and data provenance: Not applicable. The document does not describe a clinical performance study with a test set of patient data. The "study" is a comparison of technical specifications and intended uses against predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for performance evaluation was not explicitly established or reported for this submission. The comparison is based on the known features and regulatory clearances of predicate devices.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not described. The document focuses on device features and intended use equivalence, not on human reader performance with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone performance study was not described. The device is an ultrasound imaging system, which inherently involves human interpretation.
The type of ground truth used: Not applicable in the context of a performance study. The "ground truth" for the substantial equivalence claim would be the regulatory clearance and known performance characteristics of the predicate devices.
The sample size for the training set: Not applicable. This document does not describe the development or training of any AI or algorithmic components that would require a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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KL51837

510(k) Summary MyLab90 Ultrasound Imaging System Esaote. S.p.A.

JUL 2005

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).

807.92(a)(1)

Submitter Information

Carri Graham, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: (317) 849-1916 x103 Facsimile: (317) 577-9070

Contact Person:	Carri Graham
Date:	June 24, 2005

807.92(a)(2)

Trade Name:	(6100) MyLab90 Ultrasound Imaging System
Common Name:	Ultrasound Imaging System
Classification Name(s):	Ultrasonic pulse doppler imaging system 892.1550Ultrasonic pulsed echo imaging system 892.1560
Classification Number:	90IYN; 90IYO

807.92(a)(3)

Predicate Device(s)

Esaote, S.p.A.	7250 Ultrasound Imaging System	K982444
Esaote, S.p.A.	7350 Ultrasound Imaging System	K050326
Esaote, S.p.A.	Technos Ultrasound Imaging System	K990360
Esaote, S.p.A.	Technos Ultrasound Imaging System	K014168
Esaote, S.p.A.	Technos Ultrasound Imaging System	K023255
Phillips, Inc.	iU22 Ultrasound Imaging System	K042540

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510(k) Summary My Lab90 Ultrasound Imaging System Esaote. S.p.A.

807.92 (a)(4)

Device Description

The 6100 can drive phased (PA), convex (CA), linear array (LA) and Doppler probes.

807.92(a)(5)

Intended Use(s)

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ເຄລາຣ (ຊອງສາຕາ

(9)(1) 2017-07-26 11:08

รวมสร้างจรรมหน่ว โหวเรื่องโช

					6100 MyLab 90this submission	Technos(K990360, K014168 &K023255)Esaote, S.p.A.	7350 MyLab 50(K050326)Esaote, S.p.A	Megas(K982444)Esaote, S.p.A.	iU22 by Philips(K042540)Philips
Electrical SafetyUltrasound Safety	IEC60601-1Track 3 (Acoustic Output Display)	Esaote, S.p.A.(K990300, K014108 &K023255)this submission	IEC60601-1Track 3 (Acoustic Output Display)	Esaote, S.p.A.	IEC60601-1Track 3 (Acoustic Output Display)	Modes of operation2D, M-Mode, PW, CW, CFM,Amplitude Doppler (PD), TEI	YES	YES	YES	YES	YES
Indication for Use						CnTI	YES	YES	YES	YES	YES
OB/Fetal	YES	YES	YES	TVM	YES	YES	YES	NO	YES
Abdominal	YES	YES	YES	VPAN	YES	YES	NO	NO	YES
Intraoperative: Abdominal	YES	YES	NO	Compound Imaging	YES	YES	NO	NO	YES
Pediatric	YES	YES	YES	3D	YES	YES	YES	YES	YES
Small organ	YES	YES	YES	Imaging Frequencies	1 - 16 MHz	1.5 - 16 MHz	2 - 10 MHz	2 - 10 MHz	N/A
Neonatal Cephalic	YES	YES	YES	CFM/Doppler Frequencies	2 - 12 MHz	2 - 12 MHz	2 - 8 MHz	2 - 5 MHz	N/A
Adult Cephalic	YES	YES	YES	Tissue Velocity Mapping feature	YES	YES	YES	NO	NO
Cardiac	YES	YES	YES	Intelligent Real-Time ImageProcessing	YES	NO	NO	NO	YES
Transesophageal	YES	YES	YES	Biopsy Guidance	YES	YES	YES	N/A	N/A
Transrectal	YES	YES	YES	Biopsy Intended Uses	General Purpose, Transrectal,Transvaginal	General Purpose, Transrectal,Transvaginal	General Purpose, Transrectal,Transvaginal	General Purpose, Transrectal,Transvaginal	N/A
Transvaginal	YES	YES	YES	Display type	CRT	CRT	CRT	LCD or CRT (optional)	LCD
Peripheral Vascular	YES	YES	YES	Display Standard	SVGA	SVGA	SVGA	SVGA	N/A
Laparoscopic	YES	YES	NO	Digital Archival Capabilities	YES	YES	YES	YES	YES
Musculoskeletal (conventional & superficial)	YES	YES	YES	DICOM Classes:	Media Storage, Storage SCU	Media Storage, Storage SCU	Media Storage, StorageSCU	Media Storage, Storage SCU	N/A
Other: Urological	YES	YES	NO	VCR/Page Printer	YES	YES	YES	YES	YES
Probe Technology				M&A Capabilities	Cardiac, Vascular, OB andgeneral purpose measurements	Cardiac, Vascular, OB andgeneral purposemeasurements	Cardiac, Vascular, OB andgeneral purposemeasurements	Cardiac, Vascular, OB andgeneral purpose measurements	N/A
Phased Array	YES	YES	YES	Weight	120 kg	140 kg	90 kg	79 kgportable position:46 (w) x 23.5 (h) x 55 (d) cmuse position:46 (w) x 23.5 (h) x 68 (d) cm	N/A
Linear Array	YES	YES	YES	Dimensions	60(w) x 160(h) x 120(d) cm	60(w) x 160(h) x 105(d) cm	60(w) x 155(h) x 90(d) cm		N/A
Convex Array	YES	YES	YES
Doppler Probes	YES	YES	YES
Bi-Scan	YES	NO	NO

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ແລະຣັດ ສີແຜນການເທດລາວໄທ ນາງ ຄ.ສ. 1974 ເດີຣ໌ ແລະ ແລະສັງ

ສາມານສະຖິງ ສືແຫຼ່ງຂໍ້ມູນອື່ນ

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.

JUL 20 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Esaote, S.p.A. % Ms. Carri Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K051837

Trade Name: MyLab 90 Ultrasound Imaging Systems, Model 6100 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 5, 2005 Received: July 6, 2005

Dear Ms. Graham:

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 MyLab 90 Ultrasound Imaging Systems, Model 6100, as described in your premarket notification:

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Transducer Model Number

BS230	LA532
CA123	LP323
CA421	PA023
CA430	PA121
CA621	PA122
EC123	PA230
IOE323	TEE022
LA424	TRT23
LA522	2 CW
LA523	5CW

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is elassified (660 additional controls. Existing major regulations affecting your devices a It may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA cun oe found in the Overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of actived that I Dr is as an that your device complies with other requirements of the Act that I DA has made a acterimentions administered by other Federal agencies. You must of ally I cactares and regalations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers In Appendix U, (encrosou) of the Sames tic Ultrasound Systems and Transducers." If the special beeking Mantening Orcultains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and The special report blocked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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

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

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 If you desire specific at notiation at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisolanding by reference to preneesnonsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

NancyCbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Mod. 6100

KD51837

						Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Abdominal		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Intraoperative Neurological
Pediatric		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Small Organ (specify)		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Neonatal Cephalic		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Adult Cephalic		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Cardiac		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Transesophageal		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Transrectal		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Transvaginal		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Laparoscopic		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Muscolo-skeletalConventional		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Muscolo-skeletal Superficial		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)
Other (Urological)		N	N	N	N	N	N	N	N (seeNote 1)	N (seeNote 2)

Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scieroterapy Intraoperative_(Abdominal)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.
Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media) 30 VPan TVM (Tissue Velocity Mapping) Compound

Marci C. Brossdon
(Division Sign-Off)

Divisio ductive and Radiological Devices 510(k) Number

Prescription Use

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

100 000S11
------------------------

Clinical Application	Mode of Operation
	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Cardiac		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media)

3D VPan Compound

Nancy C. Hogdon

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

Prescription Use

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

		Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Neonatal Cephalic		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Adult Cephalic									N (seeNote 1)	N (seeNote 2)
Cardiac		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments:

Small Organs (thyroid, testicles, penis and breast);

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancyc Broylon

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

Prescription Use

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

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Abdominal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)
Intraoperative Neurological									N (seeNote 1)	N (seeNote 2)
Pediatric		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial									N (seeNote 1)	N (seeNote 2)
Other (Urological)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)

Additional Comments:

Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy Choydon

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

Prescription Use

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

						Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Abdominal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
LaparoscopicMuscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments:

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy C. hogdon

(Division Sign-Off) Division of Reproductive, Abdomin anr Radiological Devices 131 ·· lik, Number _______________________________________________________________________________________________________________________________________________________________

Prescription Use

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

6ﯽ1	1

						Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Abdominal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)

Additional Comments:

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; Ooklakions: uny oombination B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media) 3D VPan Compound
Nancy C Brogdon

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

Prescription Use

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

						Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Transvaginal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)

Note (1): Conbinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media)

30
VPan
Compound

Nancy C. Brogdon

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

Prescription Use

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

11
--------

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative Neurological
Pediatric		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Muscolo-skeletal Superficial		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Other (Urological)

Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scieroterapy Intraoperative (Abdominal)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy C. Brogdon

(Division Sign-Off) Abdomin Division of Reproductive, and Radiological Devices Ki 510(k) Number __

Prescription Use

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

0œ
--------

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Muscolo-skeletal Superficial		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Other (Urological)

Additional Comments:

Additional Organs (thereid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K051837 ! (1)(k) Number ______________________________________________________________________________________________________________________________________________________________

Prescription Use

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

	114
--	-------------	--

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Muscolo-skeletal Superficial		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Other (Urological)

Additional Comments:

Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy C. Broadon

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

Transcription Use

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

|--|--|

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Muscolo-skeletalConventional		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Muscolo-skeletal Superficial		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Other (Urological)

Additional Comments:

Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Nancy Croglon
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 5 10(k) Number _ 1,05

....mission 6152.

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

|--|--|

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
LaparoscopicMuscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments: Small Organs (thyroid, testicles, penis and breast); Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+CFM, B+CFM+PW where all single modes are live.
Note (2): TEI (Tissue Enhanced Imaging) mode

CnTI (Contrast Media) 30 VPan Compound

Nancy brondon

Division Sign-Off

timelon of Reproductive, Abdominal, . Padiological Devices · : )(k) Number _

Description C52

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

Am
----

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic	N	N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media) 3D

VPan Compound
Nancy C. hogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __ 13

Description #2

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

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)
Neonatal Cephalic		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Adult Cephalic
Cardiac		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments: Peripheral Vascular to include Vein Mapping & Scleroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode CnTI (Contrast Media) 30 VPan TVM (Tissue Velocity Mapping) Compound

Nancy C. Brogdon

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

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

C	1
---	---

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic									N (seeNote 1)	N (seeNote 2)
Cardiac		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)

Note (1): Combinations: any combination of the following modes: B+M+PW+CFM+PD, where only one mode is live; .

CnTI (Contrast Media)

3D VPan TVM (Tissue Velocity Mapping) Compound

Nancy Boydon
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

Commission #32

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

	1
0

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)
Neonatal Cephalic		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Adult Cephalic
Cardiac		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)

Additional Comments:

Peripheral Vascular to include Vein Mapping & Scieroterapy

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TE1 (Tissue Enhanced Imaging) mode CnTI (Contrast Media)

3D VPan TVM (Tissue Velocity Mapping) Compound

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomi and Radiological Devices 510(k) Number

Number

3 --------------------------------------------------------------------------------------------------------------------------------------------------------------------------V

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

604.441
---------------------	--

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic									N (seeNote 1)	N (seeNote 2)
Adult Cephalic		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Cardiac		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (Urological)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode

CnTI (Contrast Media) 30 VPan TVM (Tissue Velocity Mapping) Compound

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1051831 17 ---

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

TEE022

Clinical Application	Mode of Operation								Combined(specify)	Other(specify)
	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Transesophageal		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial

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

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live; B+CFM, M+CFM, B+PW, B+M, B+CFM+PW where all single modes are live.

Note (2): TEI (Tissue Enhanced Imaging) mode

CnTI (Contrast Media) 30 VPan TVM (Tissue Velocity Mapping) Compound

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices KO51837 510(k) Number _

C. 22-2002-52

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

Clinical Application	Mode of Operation
	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal									N (seeNote 1)	N (seeNote 2)
Transrectal		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial									N (seeNote 1)	N (seeNote 2)

Note (1): Combinations: any combination of the following modes: B+M+PW+CW+CFM+PD, where only one mode is live;
Childer (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) ( Oombinational only on J O+M, B+CFM+PW where all single modes are live.

Note (2): TE1 (Tissue Enhanced Imaging) mode

CnTI (Contrast Media) 30 VPan Compound
Nancy C. Brogdon

Onlinision Sign-Off) "isson of Reproductive, Abdominal, ്ങ Radiological Devices ¥051837 10(k) Number -----------------------------------------------------------------------------------------------------------------------------------------------------------------

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

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletal Superficial
Other (specify)

Other (Orological)
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Nancy C. Hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal
and Radiological Devices KUSI 837 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Clinical Application	Mode of Operation
	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					N
LaparoscopicMuscolo-skeletal
Conventional
Muscolo-skeletal Superficial

Other \Urological/
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Additional Commonta:
Penpheral Vascular to include Vein Mapping & Scieroterapy

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal ind Radiological Devices ் 10(k) Number _______________________________________________________________________________________________________________________________________________________________

initialization

✓

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.