MYLAB 70 ULTRASOUND IMAGING SYSTEM

• K Number: K051308
• Device Name: MYLAB 70 ULTRASOUND IMAGING SYSTEM
• Manufacturer: ESAOTE, S.P.A.
• Date Cleared: 2005-06-01 ( 13 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K982444 , K994369 , K050326 , K014168 , K023255
• Predicate For: K052805 , K060827 , K091009 , K103152

Intended Use

Esaote's MyLab70 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 and Other: Urologic.

Device Description

The MyLab 70 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The MyLab70 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 MyLab70 can drive phased (PA), convex (CA), linear array (LA) and Doppler probes.

The MyLab70 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 accessory devices available for the MyLab70 include a S-VHS video recorder and a monochrome or color page printer. The MyLab70 is equipped with an isolation transformer to adequately insulate the system's peripherals.

AI/ML Overview

The provided text is a 510(k) Summary for the MyLab70 Ultrasound Imaging System. It outlines the device description, intended uses, and technological characteristics by comparing it to predicate devices. However, this document does not contain acceptance criteria or the results of a study designed to prove the device meets specific performance criteria.

The 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving that the new device meets predefined, quantitative acceptance criteria through a specific performance study in the way a clinical trial for a novel device would. The "technological characteristics" table provides a comparison of features and indications for use, but this is not a performance study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the document:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics for the device itself. Instead, the acceptance for this 510(k) is based on the device demonstrating "substantial equivalence" in intended use and technological characteristics to predicate devices. The technological characteristics table lists features and modes of operation that are present in the MyLab70 and its predicates, which implies these features are considered acceptable if they function similarly to the predicates.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, dice score, etc.) are reported for the MyLab70 in this document. The document primarily attests to the presence of certain features and modes of operation.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (MyLab70, as per this document)
Electrical Safety: Conform to IEC60601-1	Meets IEC60601-1
Ultrasound Safety: Track 3 Acoustic Output Display	Track 3 (Acoustic Output Display)
Indication for Use (OB/Fetal, Abdominal, etc.)	YES for all listed indications (matches predicates)
Probe Technology (Phased Array, Linear, Convex, Doppler)	YES for all listed probe technologies (matches predicates)
Modes of Operation (2D, M-Mode, PW, CW, CFM, PD, TEI)	YES for all listed modes (matches predicates)
Imaging Frequencies: 1-16 MHz	1-16 MHz
CFM/Doppler Frequencies: 2-12 MHz	2-12 MHz
Tissue Velocity Mapping feature: YES	YES
Biopsy Guidance Intended Uses (General Purpose, Transrectal, Transvaginal)	General Purpose, Transrectal, Transvaginal (matches predicates)
Display type: CRT	CRT
Display Standard: SVGA	SVGA
Digital Archival Capabilities: YES	YES
DICOM Classes: Media Storage, Storage SCU	Media Storage, Storage SCU
VCR / Page Printer: YES	YES
M&A Capabilities: Cardiac, Vascular, OB, general purpose measurements	Cardiac, Vascular, OB, general purpose measurements
Bi-Scan: YES (for MyLab70, but NO for some predicates)	YES (This is a differentiating feature from some predicates, but it's not a performance metric)
CnTI: YES (for MyLab70, but NO for one predicate)	YES
VPAN: YES (for MyLab70, but NO for one predicate)	YES

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• This information is not provided in the document. The 510(k) summary does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not provided as no specific ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not provided as there is no mention of a test set or adjudication process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This information is not provided. This document describes an ultrasound imaging system, not an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This information is not provided. This is not an AI algorithm but an ultrasound imaging system, so standalone performance in that context is not applicable or discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• This information is not provided as no specific ground truth for a performance study is mentioned. The "ground truth" for this 510(k) is implicitly the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• This information is not provided. This is not an AI/machine learning device, so the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established:

• This information is not provided as it's not an AI/machine learning device.

Summary

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K051388

510(k) Summary MyLab70 Ultrasound Imaging System Esaote, S.p.A.

JUN 1 - 2005

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).

807.92(a)(1)

Submitter Information

Carri Graham, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: [phone] x103 Facsimile: [phone]

Contact Person:	Carri Graham
Date:	May 16, 2005
807.92(a)(2)
Trade Name:	(6150) MyLab70 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.	7250 Ultrasound Imaging System	K994369
Esaote, S.p.A.	7350 Ultrasound Imaging System	K050326
Esaote, S.p.A.	Technos Ultrasound Imaging System	K014168
Esaote, S.p.A.	Technos Ultrasound Imaging System	K023255

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510(k) Summarv MyLab70 Ultrasound Imaging System Esaote, S.p.A.

807.92 (a)(4)

Device Description

The MyLab 70 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The MyLab70 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 MyLab70 can drive phased (PA), convex (CA), linear array (LA) and Doppler probes.

The MyLab70 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 accessory devices available for the MyLab70 include a S-VHS video recorder and a monochrome or color page printer. The MyLab70 is equipped with an isolation transformer to adequately insulate the system's peripherals.

807.92(a)(5)

Intended Use(s)

Esaote's MyLab70 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 and Other: Urologic.

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510(k) Summary MyLab70 Ultrasound Imaging System Esaote, S.p.A.

807.92(a)(6)

Technological Characteristics

	MyLab 70	Technos	7350 MyLab 50
	this submission	(K014168 & K023255)	(K050326)
Electrical Safety	IEC60601-1	IEC60601-1	IEC60601-1
Ultrasound Safety	Track 3 (Acoustic	Track 3 (Acoustic	Track 3 (Acoustic Output
	Output Display)	Output Display)	Display)
Indication for Use
OB/Fetal	YES	YES	YES
Abdominal	YES	YES	YES
Pediatric●	YES	YES	YES
Small organ�	YES	YES	YES
Neonatal Cephalic	YES	YES	YES
Adult Cephalic	YES	YES	YES
Cardiac�	YES	YES	YES
Transesophageal	YES	YES	YES
Transrectal�	YES	YES	YES
Transvaginal	YES	YES	YES
Peripheral Vascular�	YES	YES	YES
Musculoskeletal	YES	YES	YES
(conventional & superficial)
Probe Technology
Phased Array	YES	YES	YES
Linear Array	YES	YES	YES
Convex Array	YES	YES	YES
Doppler Probes●	YES	YES	YES
Bi-Scan	YES	NO	NO
Modes of operation
2D, M-Mode, PW, CW, CW, CFM,	YES	YES	YES
Amplitude Doppler (PD), TEI
CnTI	YES	YES	No
TVM	YES	YES	YES
VPAN	YES	YES	NO
Imaging Frequencies	1 =16 MHz	1.5 =16 MHz	2 = 10 MHz
CFM/Doppler Frequencies	2 =12 MHz	2 ÷12 MHz	2 = 8 MHz
Tissue Velocity Mapping feature	YES	YES	YES
Biopsy Guidance
Biopsy Intended Uses	General Purpose,	General Purpose,	General Purpose,
	Transrectal,	Transrectal,	Transrectal, Transvaginal
	Transvaginal	Transvaginal
Display type	CRT	CRT	CRT
Display Standard	SVGA	SVGA	SVGA
Digital Archival Capabilities	YES	YES	YES
	MyLab 70	Technos	7350 MyLab 50
	this submission	(K014168 & K023255)	(K050326)
DICOM Classes:	Media Storage,Storage SCU	Media Storage, StorageSCU	Media Storage, StorageSCU
VCR / Page Printer	YES	YES	YES
M&A Capabilities	Cardiac, Vascular, OBand general purposemeasurements	Cardiac, Vascular, OBand general purposemeasurements	Cardiac, Vascular, OBand general purposemeasurements
Weight	110 kg	140 kg	90 kg
Dimensions	60(w) x 160(h) x90(d) cm	60(w) x 160(h) x105(d) cm	60(w) x 155(h) x 90(d)cm

9

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510(k) Summary MyLab70 Ultrasound Imaging System Esaote, S.p.A.

:

·

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

JUN 1 - 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: K051308

Trade Name: Model 6150 (MyLab70) Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory 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: May 16, 2005 Received: May 19, 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 Model 6150 (MyLab70) Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

CA123	CA430
CA421	CA621

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Page 2 - Ms. Graham

EC123	PA230
LA424	TEE022
LA522	TRT23
LA523	2CW
LA532	5CW
PA121	BS230
PA122	PA023

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This 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 Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains 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 prominently marked "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 predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation over); production over); production on itiled,

.

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Page 2 - Ms. Graham

"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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 [phone].

Sincerely yours,

Rate Phelps

fa

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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	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 (seeNote 1)	N (seeNote 2)
Abdominal		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Small Organ (specify)		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Neonatal Cephalic		N	N	N	N	N	N		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		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
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		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Laparoscopic
Musculo-skeletalConventional		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Musculo-skeletalSuperficial		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Other (Urological)		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 & Scleroterapy

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

Nole (2): TEI (Tissue Enhanced Imaging) mode Bi-Scan

Rati Pallys

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

Prescription Use

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

	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)IntraoperativeNeurological
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
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)
LaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficial
Other

Additional Comments:

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

Peripheral Vascular to include Vein Mapping & Scleroterapy

Note ( ) : 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+M, B+CFM+PW where all single modes are live.

Rat A. Pales

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

Prescription Use

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

C1		0	1414	4
	1

Clinical Application	Mode of Operation
	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)
IntraoperativeNeurological
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-skeletalSuperficial
Other (Urological)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)

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+M, B+CFM+PW where all single modes are live.

Ra. A. Phillips

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 2051308 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)IntraoperativeNeurological
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-skeletalConventionalMuscolo-skeletalSuperficial

Note ( ): Combination: ary combination of the following modes: B+M+PW +CFM+PD, where only one mode is live, B+CFM, M+CFM, B+PW,
B+M, B+CFM+PW where

Ra-C. Phillips

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

Prescription Use

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

C11	A4	62	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)IntraoperativeNeurological
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)
LaparoscopicMusculo-skeletalConventionalMusculo-skeletal
Superficial
Other (Urological)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)

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

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

Rate Phillips

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

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11	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
Intraoperative (specify)
IntraoperativeNeurological
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
LaparoscopicMusculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Urological)		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)

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+M, B+CFM+PW where all single modes are live.

Ra-Ce Phillips

(Dwision Sign-Off) Oversion of Reproductive, Abdominal, and Radiological Devices 5, "")(k) Number __

Prescription Use

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

LA424

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

Additional Comments:

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

Note (1): Combinations: ary combination of the following modes: B+M+PW +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

Ra-G. Phillips

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

Description else

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

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		N	N	N		N	N		N (seeNote 1)
Small Organ (specify)		N	N	N		N	N		N (seeNote 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (seeNote 1)
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N		N (seeNote 1)
Musculo-skeletalSuperficial		N	N	N		N	N		N (seeNote 1)
Other

Additional Comments:

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

Note ( ); 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+M, B+CFM+PW where all single modes are live.

Ra. C. Pales

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 519(k) Number __

• 1 - 5 - 5 - 5 - 5 - 5 - 5 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 -

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

|--|

				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)IntraoperativeNeurological
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)
LaparoscopicMusculo-skeletal									N (see	N (see
Conventional		N	N	N		N	N		Note 1)	Note 2)
Musculo-skeletalSuperficial		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Other

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+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

Ra. A. Phillips

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

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

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)
IntraoperativeNeurological
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
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

Additional Comments:

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

1

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

Ra. A. Palla

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

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

	-
o

	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)IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N		N (seeNote 1)	N (seeNote 2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other

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+M, B+CFM+PW where all single modes are live.
Note (2): TEI (Tissue Enhanced Imaging) mode

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

Ra-Ce Palla

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 900 ා ම(k) Number _______________________________________________________________________________________________________________________________________________________________

Image /page/17/Picture/7 description: The image shows a white background with some black markings. On the left side of the image, there are some scattered black marks that appear to be part of a word or phrase. On the right side of the image, there is a long, thin black line that extends diagonally from the bottom left to the top right.

{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)
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		N (seeNote 1)
Small Organ (specify)
Neonatal Cephalic		N	N	N	N	N	N		N (seeNote 1)
Adult Cephalic
Cardiac		N	N	N	N	N	N		N (seeNote 1)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular									N (seeNote 1)
Peripheral Vascular		N	N	N	N	N	N		N (seeNote 1)
LaparoscopicMuscolo-skeletal
Conventional
Muscolo-skeletalSuperficial
Other

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+CFM+PW where all sin

Ra-a. Pallys

(Division Sign-Off) Division of Reproductive, Abdominal, ann Radiological Devices ് D(k) Number ____

Presbyterian Life

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

	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)
IntraoperativeNeurological
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-skeletalSuperficial
Other

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

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

Ra. A. Pally

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

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

TEE022

	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)
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic										N (see
Cardiac		N	N	N	N	N	N		N (seeNote 1)
Transesophageal		N	N	N	N	N	N		N (seeNote 1)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other

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.

Rade Vally

Consion Sign-Off) asion of Reproductive, Abdominal, dialogical Devices ് സ്വാല്യ ___

Counication File

28

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

A 17.711
------------------	--

	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)IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N	N	N	N	N	N (seeNote 1)
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
LaparoscopicMuscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)		N	N	N	N	N	N	N	N (seeNote 1)

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+M, B+CFM+PW where all single modes are live.

Rate Pally

(Division Sign-Off) on ann of Reproductive. Andominal, r in meal Devices (1) (x) Number _______________________________________________________________________________________________________________________________________________________________

Organization File

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

1

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)
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
LaparoscopicMuscolo-skeletal
ConventionalMuscolo-skeletal
Superficial

Rat A. Pally

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

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

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

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
Intraoperative (specify)IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					N
LaparoscopicMuscolo-skeletalConventionalMuscolo-skeletalSuperficial
Other (Urological)

Ra-Q.P

and The Off)
Beather Diff
Beather Diff
Beather Devices Abdominal, Abdominal,
Number ്‍റി Number _________________________________________________________________________________________________________________________________________________________________

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

	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 (seeNote 1)	N (seeNote 2)
Abdominal		N	N	N	N	N	N		N (seeNote 1)	N (seeNote 2)
Intraoperative (specify)
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventionalMusculo-skeletalSuperficial
Other

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.
TEI (Tissue Enhanced Imaging) mode

Note (2): Bi-Scan

Rat. A. Pallas

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 1031300 510(k) Number ________________________________________________________________________________________________________________________________________________________________

C. G. Jung, M.D.

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

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)IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		N (seeNote 1)
Small Organ (specify)
Neonatal Cephalic		N	N	N	N	N	N		N (seeNote 1)
Adult Cephalic									N (seeNote 1)
Cardiac		N	N	N	N	N	N		N (seeNote 1)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		N (seeNote 1)
LaparoscopicMuscolo-skeletalConventionalMuscolo-skeletalSuperficial
Other

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

Rata Pally?

(Division Sign-Off) (Division Sigh Sigh - Ciry "adinlogical Devices . K, Vomber __________________________________________________________________________________________________________________________________________________________________

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.