MYLAB40

K070903 · Esaote Europe B.V. · ITX · Jul 2, 2007 · Radiology

Device Facts

• Record ID: K070903
• Device Name: MYLAB40
• Applicant: Esaote Europe B.V.
• Product Code: ITX · Radiology
• Decision Date: Jul 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

MyLab40 is a compact console ultrasound system for general diagnostic imaging. It processes acoustic signals from various probes (Phased, Convex, Linear, Doppler) to generate B-Mode, M-Mode, Doppler, 3D/4D, Color Flow Mapping, and Tissue Enhancement Imaging (TEI). Operated by clinicians in clinical settings, the system displays real-time 2D and 3D/4D images on an integrated LCD. It supports advanced features like Compound Imaging, Compass M-Mode (CMM), VPAN, Tissue Velocity Mapping (TVM), and XStrain. Output is used by physicians for diagnostic assessment and clinical decision-making. The system includes digital archival capabilities and DICOM connectivity for image storage and management. Benefits include non-invasive diagnostic visualization of internal structures and blood flow, aiding in the assessment of various disease states across multiple clinical applications.

Clinical Evidence

Bench testing only. The device was evaluated through performance testing, including acoustic output measurements, electrical safety testing (IEC60601-1), and verification of imaging modes and features against predicate systems. No clinical data was required for this 510(k) submission.

Technological Characteristics

Compact console ultrasound system; LCD display; supports Phased, Convex, Linear, and Doppler arrays. Imaging modes: 2D, M-Mode, PW/CW Doppler, CFM, Amplitude Doppler, TEI, 3D/4D. Connectivity: DICOM (Storage, Print, Worklist, MPPS). Safety: IEC60601-1, Track 3 acoustic output. Quality system: ISO9001:2000, ISO13485:2003.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body in patients requiring Cardiac, Transesophageal, Peripheral Vascular, Neonatal/Adult Cephalic, Small Organ, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, or Intraoperative/Urologic examinations.

Regulatory Classification

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.

Predicate Devices

• 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)

Submission Summary (Full Text)

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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 [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:

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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

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#### 807.92(a)(6)

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## Technological Characteristics

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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<br>To be cleared via this<br>submission | MyLab30 | MyLab20 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | | K040596<br>K052805*<br>K060827** | K043588<br>K053154****<br>K061755**** |
| Electrical Safety | IEC60601-1 | IEC60601-1 | IEC60601-1 |
| Ultrasound Safety | Track 3 (Acoustic<br>Output Display) | Track 3 (Acoustic<br>Output Display) | Track 3 (Acoustic<br>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<br>(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:<br>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,<br>CW, CFM, Amplitude<br>Doppler, TEI, 3D/4D | 2D, M-Mode, PW,<br>CW, CFM, Amplitude<br>Doppler, TEI, 3D/4D** | 2D, M-Mode, PW,<br>CFM, Amplitude<br>Doppler, TEI,<br>3D/4D*** |
| Additional Modes of<br>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<br>To be cleared via this<br>submission | MyLab30<br>K040596<br>K052805*<br>K060827** | MyLab20<br>K043588<br>K053154***<br>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,<br>8.0 MHz | 2.0, 2.5, 3.3, 5.0, 6.6,<br>8.0 MHz | 2.7, 3.5, 5.0, 6.3 MHz |
| Tissue Velocity Mapping<br>feature | YES | YES | NO |
| Biopsy Guidance | YES | YES | YES |
| • Biopsy Intended Uses | General Purpose,<br>Transrectal,<br>Transvaginal | General Purpose,<br>Transrectal,<br>Transvaginal | General Purpose,<br>Transrectal,<br>Transvaginal |
| • Biopsy Line Depth<br>marker | 1 cm | 1 cm | 1 cm |
| Needle Guide Angle | ABS421: 20° 30°<br>ABS523: 45°<br>ABS123: 3.8°<br>ABS621: 25° 35°<br>ABS424: 45°<br>BS230KIT: 12.5° 20°<br>ABS15: 45° | ABS421: 20° 30°<br>ABS523: 45°<br>ABS123: 3.8°<br>ABS621: 25° 35°<br>ABS424: 45°<br>BS230KIT: 12.5° 20°<br>ABS15: 45° | ABS421: 20° 30°<br>ABS523: 45°<br>ABS123: 3.8°<br>ABS621: 25° 35°<br>ABS424: 45°<br>ABS15: 45° |
| Display Type | SVGA | SVGA | SVGA |
| Monitor | LCD | LCD | LCD<br>CRT |
| Digital Archival<br>Capabilities | YES | YES | YES |
| DICOM Classes: | | | |
| • Image Storage | YES | YES | NO |
| • Multiframe Image<br>Storage | YES | YES | NO |
| • Basic Grayscale Print<br>Management | YES | YES | NO |
| • Basic Color Print<br>Management | YES | YES | NO |
| • Secondary Capture<br>Image Storage | YES | YES | NO |
| • Modality Worklist | YES | YES | NO |
| • Storage Commitment<br>Push Model | YES | YES | NO |
| • Modality Performed<br>Procedure Step | YES | YES | NO |
| VCR / Page Printer | YES | YES | YES |
| M&A Capabilities | Cardiac, Vascular,<br>OB, GYN and general | Cardiac, Vascular,<br>OB, GYN and general | Cardiac, Vascular,<br>OB, GYN and general |
| | MyLab40<br>To be cleared via this<br>submission | MyLab30<br>K040596<br>K052805*<br>K060827** | MyLab20<br>K043588<br>K053154***<br>K061755**** |
| Weight | 60 kg (excl. monitor) | 10 kg | 60 kg (excl. monitor) |
| Dimensions | 135 (H) x 54 (W) x 80<br>(D) cm | portable position:<br>35.5 (w) x 14 (h) x 49<br>(d) cm<br>use position:<br>35.5 (w) x 41 (h) x 49<br>(d) cm | 135 (H) x 54 (W) x 80<br>(D) cm |

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#### 510(k) Summary MyLab40

Esaote Europe

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510(k) Summary MyLab40

Esaote Europe

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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.

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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)

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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

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#### Model 2750 (MyLab40)

| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:<br>Mode of Operation | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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<br>Abdominal | | N | N | N | | N | N | | N[2] | N[3,5,7] |
| Intraoperative<br>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<br>Conventional | | N | N | N | N | N | N | | N[2] | N[3,5,9] |
| Musculo-skeletal<br>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

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## BC431

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>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<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>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

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#### BS230

| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
|----------------------------------|---|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | | N[1] | N[2,3,5,7,9] |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>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<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>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<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | | N(1) | N[2,3,4,5,7] |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>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<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>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<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | | N(1) | N[2,3,4,5,7] |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>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<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>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<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>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<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>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<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>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<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>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<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | N(2) | N[3,4,5,6,8] |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N(2) | N[3,4,6] |
| Small Organ (specify)<br>[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…