MYLAB40

• K Number: K070903
• Device Name: MYLAB40
• Manufacturer: ESAOTE EUROPE B.V.
• Date Cleared: 2007-07-02 ( 91 days)
• Product Code: ITX IYN IYO
• Regulation Number: 892.1570

Intended Use

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.

Predicate Devices

K043588, K053154, K061755, K040596, K052805, K060827

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with various imaging modes and capabilities, but there is no mention of AI or ML in the device description, intended use, or any other section. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No
The device is used to perform diagnostic general ultrasound studies, which means it helps in identifying conditions rather than treating them.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "used to perform diagnostic general ultrasound studies".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "compact console ultrasound system" and mentions hardware components like a "LCD color display" and the ability to "drive Phased Array (PA), Convex Array (CA), Linear Array (LA) and Doppler probes." This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the MyLab40 is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• MyLab40 Function: The MyLab40 is an ultrasound system. It uses sound waves to create images of internal body structures. It does not analyze biological specimens.
• Intended Use: The intended use clearly states it performs "diagnostic general ultrasound studies" on various anatomical sites within the body. This is in vivo imaging, not in vitro analysis of specimens.

Therefore, the MyLab40 falls under the category of medical imaging devices, not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ (Thyroid, Breast and Testicles), Musculoskeletal (Conventional & Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, Urological

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K043588, K053154, K061755, K040596, K052805, K060827

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 [phone], extension 103 Phone: Facsimile: [phone]

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:

1

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.

2

510(k) Summary MyLab40 Esaote Europe

:

.

807.92(a)(6)

:

Technological Characteristics

3

:

:

:

:

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).

| | MyLab40
To be cleared via this
submission | MyLab30 | MyLab20 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | | K040596
K052805*
K060827** | K043588
K053154****
K061755**** |
| Electrical Safety | IEC60601-1 | IEC60601-1 | IEC60601-1 |
| Ultrasound Safety | Track 3 (Acoustic
Output Display) | Track 3 (Acoustic
Output Display) | Track 3 (Acoustic
Output 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, Amplitude
Doppler, TEI, 3D/4D | 2D, M-Mode, PW,
CW, CFM, Amplitude
Doppler, TEI, 3D/4D** | 2D, M-Mode, PW,
CFM, Amplitude
Doppler, TEI,
3D/4D*** |
| Additional Modes of
operation: | | | |
| • 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 | | | |
| | MyLab40
To be cleared via this
submission | MyLab30
K040596
K052805*
K060827** | MyLab20
K043588
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 Mapping
feature | 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 Depth
marker | 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 | LCD
CRT |
| Digital Archival
Capabilities | YES | YES | YES |
| DICOM Classes: | | | |
| • Image Storage | YES | YES | NO |
| • Multiframe Image
Storage | YES | YES | NO |
| • Basic Grayscale Print
Management | YES | YES | NO |
| • Basic Color Print
Management | YES | YES | NO |
| • Secondary Capture
Image Storage | YES | YES | NO |
| • Modality Worklist | YES | YES | NO |
| • Storage Commitment
Push Model | YES | YES | NO |
| • Modality Performed
Procedure 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 |
| | MyLab40
To be cleared via this
submission | MyLab30
K040596
K052805*
K060827** | MyLab20
K043588
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) cm
use position:
35.5 (w) x 41 (h) x 49
(d) cm | 135 (H) x 54 (W) x 80
(D) cm |

3

510(k) Summary MyLab40

Esaote Europe

. . .

1

.

:

:

:

:

.

:

.

4

: 上一

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : i

:

:

.

4

510(k) Summary MyLab40

Esaote Europe

:

.

.

:

.

: :

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

:

:

.

:

100 million in the state

.

:

5

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:

6

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 [phone]. 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 [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 Ewa Czerska at [phone].

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)

8

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 | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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] |
| Intraoperative
Abdominal | | N | N | N | | N | N | | N[2] | N[3,5,7] |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | N | N | N | N | N | N | | N[2] | N[3,5,9] |
| Musculo-skeletal
Superficial | | 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)

lo

(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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	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)
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Muscolo-skeletal
Superficial
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)

7. 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 | A | B | M | PWD
(PW) | CWD
(CW) | Color
Doppler
(CFM) | Amplitude
Doppler
(PD) | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|----------------------------------|---|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | | N[1] | N[2,3,5,7,9] |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | |
| Muscolo-skeletal
Superficial | | | | | | | | | | |
| 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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N		N(1)	N[2,3,4,5,7]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Muscolo-skeletal
Superficial
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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		N	N	N	N	N	N		N(1)	N[2,3,4,5,7]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Muscolo-skeletal
Superficial
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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Muscolo-skeletal
Superficial
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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Muscolo-skeletal
Superficial
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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N(2)	N[3,4,5,6,8]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N(2)	N[3,4,6]
Muscolo-skeletal
Superficial		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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N[2]	N[3,4,5,6,8]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletal
Superficial		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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N[2]	N[3,4,5,6,8]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletal
Superficial		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)

09

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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N(2)	N[3,4,5,6,8]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N(2)	N[3,4,6]
Muscolo-skeletal
Superficial		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 | A | B | M | PWD
(PW) | CWD
(CW) | Color
Doppler
(CFM) | Amplitude
Doppler
(PD) | Color
Velocity
Imaging | 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] |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | N | N | N | | N | N | | N[2] | N[3,4,6] |
| Muscolo-skeletal
Superficial | | 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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	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]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N(2)	N[3,4,6]
Muscolo-skeletal
Superficial		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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	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]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletal
Superficial		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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N[2]	N[3,4,5,6,8]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletal
Superficial		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 | A | B | M | PWD
(PW) | CWD
(CW) | Color
Doppler
(CFM) | Amplitude
Doppler
(PD) | Color
Velocity
Imaging | 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] |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | N | N | N | | N | N | | N[2] | N[3,4,6] |
| Muscolo-skeletal
Superficial | | 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

16

25

CA430E

	Mode of Operation
Clinical Application	A	B	M	PWD
(PW)	CWD
(CW)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	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]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletal
Superficial		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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N[2]	N[3,4,5,6,8]
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N[2]	N[3,4,6]
Muscolo-skeletal
Superficial		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

1

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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Muscolo-skeletal
Superficial
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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Muscolo-skeletal
Superficial
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	A	B	M	PWD (PW)	CWD (CW)	Color Doppler (CFM)	Amplitude Doppler (PD)	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N(2)	N[3,4,5,6,8]
Intraoperative
Abdominal		N	N	N		N	N		N(2)	N[3,4,6,8]
Intraoperative
Neurological
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-skeletal
Conventional		N	N	N		N	N		N(2)	N[3,4,6]
Muscolo-skeletal
Superficial		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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		N	N	N		N	N		N[1]	N[2,3,4]
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Muscolo-skeletal
Superficial
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

• 2. 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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					N
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal
Superficial
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)	Color
Doppler
(CFM)	Amplitude
Doppler
(PD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					N
Laparoscopic
Muscolo-skeletal
Conventional
Muscolo-skeletal
Superficial
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.

. . .

.

11

:

..

And Children Children

1994

11 - 1

34

B
O
O
O
R

Probe	Type	Indications for Use	Clearance Method
PA230E	Phased Array	Abdominal, Adult
Cephalic, Cardiac	Cleared via K040596
PA121E	Phased Array	Abdominal, Cardiac,
Peripheral Vascular	Cleared via K050326 & Memorandum to
File referencing K040596
PA122E	Phased Array	Pediatric, Neonatal
Cephalic, Cardiac,
Peripheral Vascular	Cleared via K040596
PA023E	Phased Array	Pediatric, Neonatal
Cephalic, Cardiac,
Peripheral Vascular	Cleared via K050326 & Memorandum to
File referencing K040596
LA523	Linear Array	Abdominal, Neonatal
Cephalic, Small organ,
Peripheral Vascular,
Pediatric, Musculoskeletal
Conventional & Superficial	Cleared via K043588 & 040596
LA522E	Linear Array	Abdominal, Small organ,
Peripheral Vascular,
Pediatric, Musculoskeletal
Conventional & Superficial	Cleared via K050326 & Memorandum to
File referencing K040596
LA435	Linear Array	Abdominal, Small organ,
Peripheral Vascular,
Pediatric, Musculoskeletal
Conventional & Superficial	Cleared via Memorandum to File
referencing K040596
CA421	Convex Array	Fetal, Abdominal,
Pediatric, Small organ,
Peripheral Vascular,
Musculoskeletal
Conventional &
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 to
File referencing K040596
CA123	Convex Array	Conventional &
Superficial, Urological
Abdominal, Small organ,
Cardiac, Pediatric,
Peripheral Vascular,
Neonatal Cephalic,
Musculoskeletal	Cleared via K050326 & Memorandum to
File referencing K040596
CA431	Convex Array	Conventional & Superficial
Fetal, Abdominal,
Pediatric, Small organ,
Peripheral Vascular,
Musculoskeletal	Cleared via Memorandum to File
referencing K050326
CA631	Convex Array	Conventional &
Superficial, Urological
Fetal, Abdominal,
Pediatric, Small organ,
Peripheral Vascular,
Musculoskeletal	Cleared via Memorandum to File
referencing K050326
Probe	Type	Indications for Use	Clearance Method
LA532E	Linear Array	Abdominal, Small organ,
Pediatric, Peripheral
Vascular, Musculoskeletal
Conventional & Superficial	Cleared via K050326 & Memorandum to
File referencing K040596
CA430E	Convex Array	Fetal, Abdominal, Small
organ, Peripheral Vascular,
Musculoskeletal
Conventional &	Cleared via K050326 & Memorandum to
File referencing K040596
LA424	Linear Array	Superficial, Urological
Abdominal, Small organ,
Pediatric, Peripheral
Vascular, Musculoskeletal
Conventional & Superficial	Cleared via K050326 and Memorandum to
File referencing K040596
TEE022	Linear Array	Cardiac, Transesophageal
Pediatric	Cleared via K040596
TEE122	Linear Array		Via this submission
TOE323	Convex Array	Cardiac, Transesophageal
Abdominal
Intraoperative Abdominal,
Small organ, Pediatric,
Peripheral Vascular,
Musculoskeletal	Cleared via Memorandum to File
referencing K040596
Cleared 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

													1.1
.
:		:	:
:
:	.
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :	·
. .
·	11	. · ·
:								:		,
:
	:
.	Clearance Method	Cleared via K040596	Cleared via K060827	Cleared via K060827
1 - 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, Peripheral
Vascular, Musculoskeletal
Conventional &
Superficial, Urological	Cleared via K053154 and via this submission
1	Biopsy attachment	CA621 & CA631 - Fetal,
Abdominal, Pediatric,
Small organ, Peripheral
Vascular, Musculoskeletal
Conventional &
Superficial, Urological	Cleared via K053154 and via this submission
3	Biopsy attachment	LA523, LA522E &
LA532E - Abdominal,
Small organ, Peripheral
Vascular, Pediatric,
Musculoskeletal
Conventional & Superficial	Cleared via K053154 and via this submission
4	Biopsy attachment	LA424 & LA435-
Abdominal, Small organ,
Pediatric, Peripheral
Vascular, Musculoskeletal
Conventional & 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, Adult
Cephalic, Cardiac	Cleared via K060827
ABS15	Biopsy attachment	IOE323 - Abdominal,
Small organ, Pediatric,
Peripheral Vascular,
Musculoskeletal
Conventional & Superficial	Cleared via K052805

:

.

יי יי

. ..

:

: