The MyLab40 is a compact console 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 and Other: Urologic.

Device Description

The MyLab40 is a compact console ultrasound system used to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D, Color Flow Mapping and on lower frequency probes, Tissue Enhancement Imaging (TEI). The system is equipped with a LCD color display and can drive Phased Array (PA), Convex Array (CA), Linear Array (LA) and Doppler probes. The MyLab40 is able to produce Real Time 2D images and 3D images in manual mode with all probes. The system in combination with the BC431 or BS230 probe, offer the possibility to also produce automatic 3D and Real Time 4D images. The MyLab40 is manufactured under an ISO9001:2000 and ISO13485:2003 certified quality system.

AI/ML Overview

The provided text is a 510(k) summary for the MyLab40 Ultrasound System and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document focuses on:

Device Description: General purpose ultrasound system and its modes of operation.
Intended Use: A broad range of diagnostic ultrasound studies.
Technological Characteristics: A comparison table showing the MyLab40's technical specifications and indications for use against predicate devices (MyLab30 and MyLab20). This comparison primarily asserts substantial equivalence rather than detailing specific performance criteria or a study designed to meet them.
Transducer Indications for Use: Detailed tables for various transducers outlining their applicable clinical applications and modes of operation.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your request, the input document would need to include sections detailing:

Acceptance Criteria: Specific performance thresholds the device must meet (e.g., accuracy, precision, sensitivity, specificity for a particular measurement or diagnostic task).
Study Design and Results: A description of a study conducted to demonstrate the device's performance against these criteria, including:
- Sample size and data provenance for the test set.
- Details on ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
- Whether MRMC or standalone performance studies were conducted, and their results.
- Training set details (sample size, ground truth establishment).

Summary

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510(k) Summary MyLab40 Esaote Europe

K070903

510(k) Summary

JUL - 2 2007

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 1807.92(a).

807.92(a)(1)

Submitter Information

Carri Graham, Official Correspondent 11460 N. Meridian St., Suite 150 Carmel, IN 46032 (317) 569-9500, extension 103 Phone: Facsimile: (317) 569-9520

Contact Person: Carri Graham

Date:

March 20, 2007

IYO IYN ITX

807.92(a)(2)

Trade Name:

MyLab40 Ultrasound System

Ultrasound Imaging System

Common Name:

Classification Name(s):

Ultrasonic pulsed echo imaging system 892.1560 Ultrasonic pulsed Doppler imaging system 832.1550 Diagnostic ultrasonic transducer 892.1570

Classification Number:

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510(k) Summary MyLab40 Esaote Europe

807.92(a)(3) Predicate Device(s) Pie Medical MyLab20 K043588 Pie Medical MyLab20 K053154 Esaote Europe MyLab20 K061755 Esaote S.p.A. MyLab30 K040596 Esaote S.p.A. MyLab30 K052805 Esaote S.p.A. MyLab30 K060827

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

807.92(a)(4)

Device Description

The MyLab40 is a compact console ultrasound system used to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D, Color Flow Mapping and on lower frequency probes, Tissue Enhancement Imaging (TEI). The system is equipped with a LCD color display and can drive Phased Array (PA), Convex Array (CA), Linear Array (LA) and Doppler probes. The MyLab40 is able to produce Real Time 2D images and 3D images in manual mode with all probes. The system in combination with the BC431 or BS230 probe, offer the possibility to also produce automatic 3D and Real Time 4D images. The MyLab40 is 1 manufactured under an ISO9001:2000 and ISO13485:2003 certified quality system.

807.92(a)(5)

Intended Use(s)

The MyLab40 is a compact console ultrasound system used to perform general diagnostic ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional & Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic.

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510(k) Summary MyLab40 Esaote Europe

807.92(a)(6)

Technological Characteristics

the country of the

ESAOTE believes that the MyLab40 is substantially equivalent to the Esaote's MyLab20 product (K043588, K053154 and K061755) and the Esaote's MyLab30 product (K040596, K052805 and K060827).

	MyLab40To be cleared via thissubmission	MyLab30	MyLab20
		K040596 K052805K060827*	K043588 K053154K061755
Electrical Safety	IEC60601-1	IEC60601-1	IEC60601-1
Ultrasound Safety	Track 3 (AcousticOutput Display)	Track 3 (AcousticOutput Display)	Track 3 (AcousticOutput Display)
Indication for Use:
• Cardiac	YES	YES	YES
• Transesophageal	YES	YES	NO
• Peripheral Vascular	YES	YES	YES
• Neonatal Cephalic	YES	YES	YES
• Adult Cephalic	YES	YES	NO
• Small organ	YES	YES	YES
• Musculoskeletal(conventional & superficial)	YES	YES	YES
• Abdominal	YES	YES	YES
• OB/Fetal	YES	YES	YES
• Transvaginal	YES	YES	YES
• Transrectal	YES	YES	YES
• Pediatric	YES	YES	YES
• Intraoperative:Abdominal	YES	YES*	YES****
• Other: Urological	YES	YES**	YES****
Probe Technology
• Annular Array	NO	NO	NO
• Phased Array	YES	YES	NO
• Linear array	YES	YES	YES
• Convex Array	YES	YES	YES
Modes of operation	2D, M-Mode, PW,CW, CFM, AmplitudeDoppler, TEI, 3D/4D	2D, M-Mode, PW,CW, CFM, AmplitudeDoppler, TEI, 3D/4D**	2D, M-Mode, PW,CFM, AmplitudeDoppler, TEI,3D/4D***
Additional Modes ofoperation:
• Compound Imaging	YES	YES**	No
• CMM	YES	YES**	No
• VPAN	YES	YES**	No
• CnTI	YES	YES**	No
• Strain Rate Quantification	YES	YES**	No
Esaote Europe
	MyLab40To be cleared via thissubmission	MyLab30K040596 K052805K060827*	MyLab20K043588 K053154*K061755**
TVM	YES	YES**	No
Imaging Frequencies	2.0 - 16 MHz	2.0 - 16 MHz	2.7 - 15 MHz
CFM/Doppler Frequencies	2.0, 2.5, 3.3, 5.0, 6.6,8.0 MHz	2.0, 2.5, 3.3, 5.0, 6.6,8.0 MHz	2.7, 3.5, 5.0, 6.3 MHz
Tissue Velocity Mappingfeature	YES	YES	NO
Biopsy Guidance	YES	YES	YES
• Biopsy Intended Uses	General Purpose,Transrectal,Transvaginal	General Purpose,Transrectal,Transvaginal	General Purpose,Transrectal,Transvaginal
• Biopsy Line Depthmarker	1 cm	1 cm	1 cm
Needle Guide Angle	ABS421: 20° 30°ABS523: 45°ABS123: 3.8°ABS621: 25° 35°ABS424: 45°BS230KIT: 12.5° 20°ABS15: 45°	ABS421: 20° 30°ABS523: 45°ABS123: 3.8°ABS621: 25° 35°ABS424: 45°BS230KIT: 12.5° 20°ABS15: 45°	ABS421: 20° 30°ABS523: 45°ABS123: 3.8°ABS621: 25° 35°ABS424: 45°ABS15: 45°
Display Type	SVGA	SVGA	SVGA
Monitor	LCD	LCD	LCDCRT
Digital ArchivalCapabilities	YES	YES	YES
DICOM Classes:
• Image Storage	YES	YES	NO
• Multiframe ImageStorage	YES	YES	NO
• Basic Grayscale PrintManagement	YES	YES	NO
• Basic Color PrintManagement	YES	YES	NO
• Secondary CaptureImage Storage	YES	YES	NO
• Modality Worklist	YES	YES	NO
• Storage CommitmentPush Model	YES	YES	NO
• Modality PerformedProcedure Step	YES	YES	NO
VCR / Page Printer	YES	YES	YES
M&A Capabilities	Cardiac, Vascular,OB, GYN and general	Cardiac, Vascular,OB, GYN and general	Cardiac, Vascular,OB, GYN and general
	MyLab40To be cleared via thissubmission	MyLab30K040596 K052805K060827*	MyLab20K043588 K053154*K061755**
Weight	60 kg (excl. monitor)	10 kg	60 kg (excl. monitor)
Dimensions	135 (H) x 54 (W) x 80(D) cm	portable position:35.5 (w) x 14 (h) x 49(d) cmuse position:35.5 (w) x 41 (h) x 49(d) cm	135 (H) x 54 (W) x 80(D) cm

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510(k) Summary MyLab40

Esaote Europe

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: 上一

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510(k) Summary MyLab40

Esaote Europe

: :

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100 million in the state

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2007

Esaote Europe B.V. % Ms. Carrie Graham Consultant The Anson Group 11460 N. Meridian St., Ste. 150 CARMEL IN 46032

Re: K070903

Trade Name: MyLab40 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: May 21, 2007 Received: May 22, 2007

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 MyLab40, as described in your premarket notification:

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Transducer Model Number
BC431	LA532E	LA424
BS230	LA435	TEE022
PA230E	CA421	TEE122
PA121E	CA621	IOE323
PA122E	CA631	EC123
PA023E	CA123	2.0 CW Probe
LA523	CA431	5.0 CW Probe
LA522E	CA430E

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 (OS) 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.

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

Page 2 - Ms. Graham

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "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 (800) 638-2041 or (240) 276-3150 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 Ewa Czerska at (240) 276-3666.

Sincerely yours,

Herbert Lemmer wo

ancy 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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Indications for Use

510(k) Number (if known):

KO70903

Device Name:

MyLab40

Indications For Use:

Esaote's MyLab40 is a compact console 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 and Other: Urologic.

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulus Pemen

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

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

Model 2750 (MyLab40)

	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		N	N	N		N	N		N[2]	N[3,4,9]
Abdominal		N	N	N	N	N	N		N[2]	N[3,4,5,7,9]
IntraoperativeAbdominal		N	N	N		N	N		N[2]	N[3,5,7]
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		N[2]	N[3,5,9]
Small Organ (specify) [1]		N	N	N	N	N	N		N[2]	N[3,5,7,9]
Neonatal Cephalic		N	N	N	N	N	N		N[2]	N[3]
Adult Cephalic		N	N	N	N	N	N		N[2]	N[3]
Cardiac		N	N	N	N	N			N[2]	N[3,4,6,8,9]
Transesophageal		N	N	N	N	N	N		N[2]	N[3,4,6,8]
Transrectal		N	N	N		N	N		N[2]	N[3,7,9]
Transvaginal		N	N	N		N	N		N[2]	N[3,7,9]
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		N[2]	N[3,5,9]
Laparoscopic									N[2]	N[3,5,9]
Musculo-skeletalConventional		N	N	N	N	N	N		N[2]	N[3,5,9]
Musculo-skeletalSuperficial		N	N	N	N	N	N		N[2]	N[3,5,9]
Other (Urological)		N	N	N	N	N	N		N[2]	N[3,5,7,9]

Intended Use: Diagnostic ultrasound imaging or thud flow onelygi

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

Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles,
[2] Applicable combined modes: B+M+PW+CW+CFM+PD
(3] Tissue Enhancement Imaging (TEI) Compound Imaging
Compass M-Mode (CMM)
VPAN
Tissue Velocity Mapping (TVM)
CnTI
XStrain
3D/4D Imaging

LEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801. 109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903

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

BC431

	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(1)	N(2,3,4,9)
Abdominal		N	N	N	N	N	N		N(1)	N(2,3,4,5,9)
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		N(1)	N(2,3,5,9)
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		N(1)	N(2,3,5,9)
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)		N	N	N	N	N	N		N(1)	N(2,3,5,7,9)

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

1 } Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) থ

Compound Imaging 31

Compass M-Mode (CMM) 41
VPAN 51

Tissue Velocity Mapping (TVM) (6)

CnTI

XStrain 81

[9] 3D/4D Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109)

Prescription Use (Per 21 CFR 801. 109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903
2

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

BS230

Clinical Application	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	N[1]	N[2,3,5,7,9]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N[1]	N[2,3]
Cardiac	N	N	N	N	N	N	N[1]	N[2,3,4,6,8,9]
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)

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

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 21

Compound Imaging 31

Compass M-Mode (CMM) ব
5] VPAN

Tissue Velocity Mapping (TVM) ાં

71 CnTI

[8] XStrain

9] 3D/4D Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Halutten

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

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

PA230E

	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(1)	N[2,3,4,5,7]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		N	N	N	N	N	N		N(1)	N[2,3]
Cardiac		N	N	N	N	N	N		N(1)	N[2,3,4,6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)

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

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 2
Compound Imaging 3

Compass M-Mode (CMM) ব

VPAN ടി

Tissue Velocity Mapping (TVM) ્રો

7] CnTI
8| XStrain
[9] 3D/4D Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (OD)B

Prescription Use (Per 21 CFR 801.109)

CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K070903
510(k) Number

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

PA121E

	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(1)	N[2,3,4,5,7]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		N(1)	N[2,3,4,6,8]
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		N(1)	N[2,3,5]
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)

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

: 上

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 21

Compound Imaging 3

Compass M-Mode (CMM) ব
VPAN റ

Tissue Velocity Mapping (TVM) 61

CnTl 7

[8] XStrain

[9] 3D/4D Imaging

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

Prescription Use (Per 21 CFR 801.109)

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

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

PA122E

Clinical Application	Mode of Operation
	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		N[1]	N(2,3,5)
Small Organ (specify)
Neonatal Cephalic		N	N	N	N	N	N		N[1]	N(2,3)
Adult Cephalic
Cardiac		N	N	N	N	N	N		N[1]	N(2,3,4,6,8)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		N[1]	N(2,3,5)
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)

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

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 21

Compound Imaging ે છે

Compass M-Mode (CMM) 41

VPAN · ടി

Tissue Velocity Mapping (TVM) ಲ

71 CnTI

XStrain 81

3D/4D Imaging ರಿ

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODE) 1 Prescription Use (Per 21 CFR 801.109)

Halid Remmo

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices AL 5 I O(k) Number ______________________________________________________________________________________________________________________________________________________________

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

PA023E

Clinical Application	Mode of Operation
	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		N(1)	N(2,3,5)
Small Organ (specify)
Neonatal Cephalic		N	N	N	N	N	N		N(1)	N(2,3)
Adult Cephalic
Cardiac		N	N	N	N	N	N		N(1)	N(2,3,4,6,8)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		N(1)	N(2,3,5)
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)

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

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

2] Tissue Enhancement Imaging (TEI)
Compound Imaging 31
Compass M-Mode (CMM) ্ব
VPAN 5

[6] Tissue Velocity Mapping (TVM)

CnTI 1
XStrain 81
[9] 3D/4D Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Heleum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices N 071 510(k) Number _

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

LA523

	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(2)	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		N(2)	N[3,4,6]
Small Organ (specify)[1]		N	N	N		N	N		N(2)	N[3,4,6,8]
Neonatal Cephalic		N	N	N		N	N		N(2)	N(3,4)
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N(2)	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N(2)	N[3,4,6]
Muscolo-skeletalSuperficial		N	N	N		N	N		N(2)	N[3,4,6]
Other (Urological)

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

[1] Small organs include Thyroid, Breast and Testicles.

2] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 3

Compound Imaging 41

Compass M-Mode (CMM) ടി

VPAN (6)

7 Tissue Velocity Mapping (TVM)

CnTI 81

9] XStrain

[10] 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODB)

Prescription Use (Per 21 CFR 80 ). 109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903. 8

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

LA522E

	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[2]	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		N[2]	N[3,4,6]
Small Organ (specify)[1]		N	N	N		N	N		N[2]	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N[2]	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletalSuperficial		N	N	N		N	N		N[2]	N[3,4,6]
Other (Urological)

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

[3] Tissue Enhancement Imaging (TEI)

Compound Imaging (4)

(S Compass M-Mode (CMM)

VPAN (6)

Tissue Velocity Mapping (TVM) 7

CnTI 8

9| XStrain

[10] 3D/4D Imaging

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

Prescription Use (Per 21 CFR 80 1.109

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903

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

LA532E

	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[2]	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		N[2]	N[3,4,6]
Small Organ (specify)[1]		N	N	N		N	N		N[2]	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N[2]	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletalSuperficial		N	N	N		N	N		N[2]	N[3,4,6]
Other (Urological)

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 31

Compound Imaging 4

Compass M-Mode (CMM) న్న

VPAN ાં છો

Tissue Velocity Mapping (TVM) 71

(8) CnTI

9| XStrain

[10] 3D/4D Imaging

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

Concession and Career

Prescription Use (Per 21 CFR 80).

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903 10

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

LA435

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(2)	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		N(2)	N[3,4,6]
Small Organ (specify)[1]		N	N	N		N	N		N(2)	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N(2)	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N(2)	N[3,4,6]
Muscolo-skeletalSuperficial		N	N	N		N	N		N(2)	N[3,4,6]
Other (Urological)

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) (3)

Compound Imaging ্ব

Compass M-Mode (CMM) 5

VPAN റ

. .

Tissue Velocity Mapping (TVM) 71

CnTI 8

9| XStrain

[10] 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (QDE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903

Out

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

Clinical Application	B	M	PWD(PW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	Combined(specify)	Other(specify)
Ophthalmic
Fetal	N	N	N	N	N	N[2]	N[3,4,5]
Abdominal	N	N	N	N	N	N[2]	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	N	N	N	N	N	N[2]	N[3,4,6]
Small Organ (specify)	N	N	N	N	N	N[2]	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N[2]	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional	N	N	N	N	N	N[2]	N[3,4,6]
Muscolo-skeletalSuperficial	N	N	N	N	N	N[2]	N[3,4,6]
Other (Urological)	N	N	N	N	N	N[2]	N[3,4,6,8]

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

Small organs include Thyroid, Breast and Testicles. 11

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 31

41 Compound Imaging

Compass M-Mode (CMM) റ
VPAN ಲ

Tissue Velocity Mapping (TVM) 7

CnTI 8

9| XStrain

10] 3D/4D Imaging

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

Prescription Use (Per 21 CFR 801.109)

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

bergelier

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

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[2]	N[3,4,5]
Abdominal		N	N	N		N	N		N[2]	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		N(2)	N[3,4,6]
Small Organ (specify)[1]		N	N	N		N	N		N(2)	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N[2]	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N(2)	N[3,4,6]
Muscolo-skeletalSuperficial		N	N	N		N	N		N(2)	N[3,4,6]
Other (Urological)		N	N	N		N	N		N[2]	N[3,4,6,8]

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

3] Tissue Enhancement Imaging (TEI)

4] Compound Imaging

Compass M-Mode (CMM) ്

VPAN 6

Tissue Velocity Mapping (TVM) 7

CnTI 81

XStrain 91

(10] 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODE Prescription Use (Per 21 CFR 801. Co

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

e, Abdominal,
K070903

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

	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[2]	N[3,4,5]
Abdominal		N	N	N		N	N		N[2]	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		N[2]	N[3,4,6]
Small Organ (specify)[1]		N	N	N		N	N		N[2]	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N[2]	N[3,4,6]
Laparoscopic									N[2]
Muscolo-skeletalConventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletalSuperficial		N	N	N		N	N		N[2]	N[3,4,6]
Other (Urological)		N	N	N		N	N		N[2]	N[3,4,6,8]

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

[3] Tissue Enhancement Imaging (TEI)

Compound Imaging 4)

Compass M-Mode (CMM) ടി

VPAN C

Tissue Velocity Mapping (TVM) 7

8] CnTI

9] XStrain

[10] 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODE) 1.109)

Prescription Use (Per 21 CFR 8)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903

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

CA123

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[2]	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		N[2]	N[3,4,6]
Small Organ (specify)[1]		N	N	N		N	N		N[2]	N[3,4,6,8]
Neonatal Cephalic		N	N	N		N	N		N[2]	N[3,4]
Adult Cephalic
Cardiac		N	N	N		N	N		N[2]	N[3,4,5,7,9]
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N[2]	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletalSuperficial		N	N	N		N	N		N[2]	N[3,4,6]
Other (Urological)

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

3] Tissue Enhancement Imaging (TEI)

[4] Compound Imaging

Compass M-Mode (CMM) ടി

[6] VPAN

Tissue Velocity Mapping (TVM) 71

81 CnTI

[9] XStrain

[10] 3D/4D Imaging

IPLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (OD) 11 11

Prescription Use (Per 21 CFR 80 ]. 109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903
1

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

Clinical Application	B	M	PWD(PW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	Combined(specify)	Other(specify)
Ophthalmic
Fetal	N	N	N	N	N	N[2]	N[3,4,5]
Abdominal	N	N	N	N	N	N[2]	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric	N	N	N	N	N	N[2]	N[3,4,6]
Small Organ (specify)[1]	N	N	N	N	N	N[2]	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N[2]	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional	N	N	N	N	N	N[2]	N[3,4,6]
Muscolo-skeletalSuperficial	N	N	N	N	N	N[2]	N[3,4,6]
Other (Urological)	N	N	N	N	N	N[2]	N[3,4,6,8]

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

Small organs include Thyroid, Breast and Testicles. 11

2] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 31

Compound Imaging ব

Compass M-Mode (CMM) C

VPAN e

Tissue Velocity Mapping (TVM) 7

CnTI 81

9] XStrain

[10] 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (OD)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. 2070903

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

CA430E

	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[2]	N[3,4,5]
Abdominal		N	N	N		N	N		N[2]	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ (specify)		N	N	N		N	N		N[2]	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N[2]	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletalSuperficial		N	N	N		N	N		N[2]	N[3,4,6]
Other (Urological)		N	N	N		N	N		N[2]	N[3,4,6,8]

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 31

4] Compound Imaging

Compass M-Mode (CMM) ടി

VPAN (6)

Tissue Velocity Mapping (TVM) (7)

8| CnTI

[9] XStrain

[10] 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CER 8011109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K07090

17-

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

LA424

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[2]	N[3,4,5,6,8]
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N		N	N		N[2]	N[3,4,6]
Small Organ (specify)[1]		N	N	N		N	N		N[2]	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N[2]	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletalSuperficial		N	N	N		N	N		N[2]	N[3,4,6]
Other (Urological)

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 31

Compound Imaging 41

Compass M-Mode (CMM) റ

VPAN 0

Tissue Velocity Mapping (TVM) 7

CnTI 81

9] XStrain

10| 3D/4D Imaging

IPLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evarqation (ODE)

Prescription Use (Per 21 CFR 801. 109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K070903

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

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
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		N[1]	N[2,3,4,6,8]
Transesophageal		N	N	N	N	N	N		N[1]	N[2,3,4,6,8]
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)

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

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 21
Compound Imaging 31
Compass M-Mode (CMM) 41
VPAN 5

Tissue Velocity Mapping (TVM) ી

CnTI 7
XStrain Comment x

3D/4D Imaging 91

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

concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR (09)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903

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

TEE122

Clinical Application	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		N(1)	N[2,3,5]
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		N(1)	N[2,3,4,6,8]
Transesophageal		N	N	N	N	N	N		N(1)	N[2,3,4,6,8]
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)

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

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

2] Tissue Enhancement Imaging (TEI)
Compound Imaging ਤ।
41 Compass M-Mode (CMM)
VPAN ടി
Tissue Velocity Mapping (TVM) િકા
CnTI 71
XStrain ાંકો
9| 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Eraluation (OPE)

Prescription Use (Per 21 CFR 801.199

FR.801.109

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070903

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

IOE323

Clinical Application	B	M	PWD (PW)	Color Doppler (CFM)	Amplitude Doppler (PD)	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N(2)	N[3,4,5,6,8]
IntraoperativeAbdominal	N	N	N	N	N	N(2)	N[3,4,6,8]
IntraoperativeNeurological
Pediatric	N	N	N	N	N	N(2)	N[3,4,6]
Small Organ (specify)[1]	N	N	N	N	N	N(2)	N[3,4,6,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N(2)	N[3,4,6]
Laparoscopic
Muscolo-skeletalConventional	N	N	N	N	N	N(2)	N[3,4,6]
Muscolo-skeletalSuperficial	N	N	N	N	N	N(2)	N[3,4,6]
Other (Urological)

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 31

Compound Imaging বা

Compass M-Mode (CMM) ടി

VPAN (ଚା

Tissue Velocity Mapping (TVM) 71

CnTI ಹಿ

9| XStrain

10] 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE AF NEEDED concurrence of CDRH, Office of Device Evaluation (OD)

Prescription Use (Per 2 1 CFR 80 1. 109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KD70903
21

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

EC123

	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[1]	N[2,3,4]
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		N[1]	N[2,3,7]
Transvaginal		N	N	N		N	N		N[1]	N[2,3,7]
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other (Urological)		N	N	N		N	N		N[1]	N[2,3,5,7]

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

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

1. Tissue Enhancement Imaging (TEI)
Compound Imaging 31
Compass M-Mode (CMM) 41
VPAN રી
Tissue Velocity Mapping (TVM) el
CnTI 71
81 XStrain
3D/4D Imaging 9

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER RAGE IF REEDED concurrence of CDRH, Office of Device Evaluation (@DD

Prescription Use (Per 21 CFR 801. 109

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5.10(k) Number _______________________________________________________________________________________________________________________________________________________________

.22

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

2.0 CW Probe

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

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

Tissue Enhancement Imaging (TEI) 31

্র | Compound Imaging

Compass M-Mode (CMM) റ

VPAN ી

Tissue Velocity Mapping (TVM) 7

CnTI 8

9] XStrain

10] 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109

(Division Sign-Off) Division of Reproductive, Abdomina 23 and Radiological Devices 510(k) Number __

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

5.0 CW Probe

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

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CW+CFM+PD

[3] Tissue Enhancement Imaging (TEI)

(4) Compound Imaging

Compass M-Mode (CMM) ടി

VPAN (୧)

Tissue Velocity Mapping (TVM) 71
CnTI 81
9| XStrain
[10] 3D/4D Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEED concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division SignVOff) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

The following section is page numbered independently from the remainder of the submission.

. . .

And Children Children

1994

11 - 1

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

B
O
O
O
R

Probe	Type	Indications for Use	Clearance Method
PA230E	Phased Array	Abdominal, AdultCephalic, Cardiac	Cleared via K040596
PA121E	Phased Array	Abdominal, Cardiac,Peripheral Vascular	Cleared via K050326 & Memorandum toFile referencing K040596
PA122E	Phased Array	Pediatric, NeonatalCephalic, Cardiac,Peripheral Vascular	Cleared via K040596
PA023E	Phased Array	Pediatric, NeonatalCephalic, Cardiac,Peripheral Vascular	Cleared via K050326 & Memorandum toFile referencing K040596
LA523	Linear Array	Abdominal, NeonatalCephalic, Small organ,Peripheral Vascular,Pediatric, MusculoskeletalConventional & Superficial	Cleared via K043588 & 040596
LA522E	Linear Array	Abdominal, Small organ,Peripheral Vascular,Pediatric, MusculoskeletalConventional & Superficial	Cleared via K050326 & Memorandum toFile referencing K040596
LA435	Linear Array	Abdominal, Small organ,Peripheral Vascular,Pediatric, MusculoskeletalConventional & Superficial	Cleared via Memorandum to Filereferencing K040596
CA421	Convex Array	Fetal, Abdominal,Pediatric, Small organ,Peripheral Vascular,MusculoskeletalConventional &Superficial, Urological	Cleared via K040596
Probe	Type	Indications for Use	Clearance Method
CA621	Convex Array	Fetal, Abdominal,Pediatric, Small organ,Peripheral Vascular,Musculoskeletal	Cleared via K050326 & Memorandum toFile referencing K040596
CA123	Convex Array	Conventional &Superficial, UrologicalAbdominal, Small organ,Cardiac, Pediatric,Peripheral Vascular,Neonatal Cephalic,Musculoskeletal	Cleared via K050326 & Memorandum toFile referencing K040596
CA431	Convex Array	Conventional & SuperficialFetal, Abdominal,Pediatric, Small organ,Peripheral Vascular,Musculoskeletal	Cleared via Memorandum to Filereferencing K050326
CA631	Convex Array	Conventional &Superficial, UrologicalFetal, Abdominal,Pediatric, Small organ,Peripheral Vascular,Musculoskeletal	Cleared via Memorandum to Filereferencing K050326
Probe	Type	Indications for Use	Clearance Method
LA532E	Linear Array	Abdominal, Small organ,Pediatric, PeripheralVascular, MusculoskeletalConventional & Superficial	Cleared via K050326 & Memorandum toFile referencing K040596
CA430E	Convex Array	Fetal, Abdominal, Smallorgan, Peripheral Vascular,MusculoskeletalConventional &	Cleared via K050326 & Memorandum toFile referencing K040596
LA424	Linear Array	Superficial, UrologicalAbdominal, Small organ,Pediatric, PeripheralVascular, MusculoskeletalConventional & Superficial	Cleared via K050326 and Memorandum toFile referencing K040596
TEE022	Linear Array	Cardiac, TransesophagealPediatric	Cleared via K040596
TEE122	Linear Array		Via this submission
TOE323	Convex Array	Cardiac, TransesophagealAbdominalIntraoperative Abdominal,Small organ, Pediatric,Peripheral Vascular,Musculoskeletal	Cleared via Memorandum to Filereferencing K040596Cleared via K052805 & K061755

{35}------------------------------------------------

ndications for Use for Transducers / Biopsy Attachments
Chications for Use for Transducers / Biopsy Attachments
Comments of

: 上一篇:

{36}------------------------------------------------

adications for Use for Transducers / Biopsy Attachments

{37}------------------------------------------------



.:		:	:::	.: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :	·. .·	11	. · ·:							:	,:
	:.	Clearance Method	Cleared via K040596	Cleared via K060827	Cleared via K0608271 - 14 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 -	Cleared via K052805	Via this submission	Via this submission	Cleared via K052805					:		,
ndications for Use for Transducers / Biopsy Attachments		Indications for Use	Fetal, Urological, Transrectal, Transvaginal Abdominal, Adult Abdominal, Adult Cephalic, Cardiac		Fetal, Abdominal, Pediatric, Peripheral Vascular, Urological	:Vass Cardiac, Cardiac, Cardiac, Cardiac, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardia, Cardi	Peripheral Vascular	Cardiac,	Peripheral Vascular	1. 1	:
						1	,在								ा म	:
		Type	Linear Array	hased Array	Convex Array	Doppler Array		Doppler Arra				:	:
		:
		Probe	EC123	BS230	BC431	2.0 CW		5.0 CW

{38}------------------------------------------------

n ications for Use for Transducers / Biopsy Attachments

	Type	Indications for Use	Clearance Method
1	Biopsy attachment	CA421, CA430E &CA431- Fetal, Abdominal,Small organ, PeripheralVascular, MusculoskeletalConventional &Superficial, Urological	Cleared via K053154 and via this submission
1	Biopsy attachment	CA621 & CA631 - Fetal,Abdominal, Pediatric,Small organ, PeripheralVascular, MusculoskeletalConventional &Superficial, Urological	Cleared via K053154 and via this submission
3	Biopsy attachment	LA523, LA522E &LA532E - Abdominal,Small organ, PeripheralVascular, Pediatric,MusculoskeletalConventional & Superficial	Cleared via K053154 and via this submission
4	Biopsy attachment	LA424 & LA435-Abdominal, Small organ,Pediatric, PeripheralVascular, MusculoskeletalConventional & Superficial	Cleared via K053154 and via this submission
5	Biopsy attachment	EC123 - Fetal, Urology,Transrectal Transvaginal	Cleared via K040596

: 上

{39}------------------------------------------------

Biopsy Attachments	Type	Indications for Use	Clearance Method
BS230 Kit	Biopsy attachment	BS230 - Abdominal, AdultCephalic, Cardiac	Cleared via K060827
ABS15	Biopsy attachment	IOE323 - Abdominal,Small organ, Pediatric,Peripheral Vascular,MusculoskeletalConventional & Superficial	Cleared via K052805

יי יי

. ..

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.