MYLABGOLD

K110688 · Esaote · IYO · Jun 2, 2011 · Radiology

Device Facts

• Record ID: K110688
• Device Name: MYLABGOLD
• Applicant: Esaote
• Product Code: IYO · Radiology
• Decision Date: Jun 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-skeletal applications. The 7340 system provides imaging for venous system measurements.

Device Story

Model 7340 is a portable ultrasound system for diagnostic general studies. It processes inputs from various transducers (phased, convex, linear, Doppler, BiScan) to generate B-Mode, M-Mode, Doppler, Color Flow Mapping, Amplitude Doppler, Tissue Velocity Mapping, and Tissue Enhancement Imaging. The upgrade adds venous imaging software, including dedicated presets, optimized probe management for venous intracranial Doppler, and a Quality Doppler Profiles (QDP) technology based on a multigate Doppler algorithm. Operated by clinicians in clinical settings, the system displays images on an LCD and allows data entry via an alphanumeric keyboard. Images are stored on an internal hard disk, DVD-RW, or external media via LAN/USB. The output assists physicians in venous measurements and clinical decision-making, potentially improving diagnostic accuracy for venous system conditions.

Clinical Evidence

Bench testing only. Verification and validation tests were conducted in accordance with design controls per 21 CFR 820.30, confirming compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, and AIUM/NEMA standards for acoustic output.

Technological Characteristics

Portable ultrasound system with LCD display, internal hard disk, and DVD-RW. Supports phased, convex, linear, Doppler, and BiScan transducers. Connectivity via LAN/USB. Complies with IEC 60601-1 and IEC 60601-2-37. Software includes venous imaging package with multigate Doppler algorithm. Manufactured under ISO 9001:2000 and ISO 13485 certified quality system.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring general ultrasound studies, including cardiac, vascular, abdominal, fetal, small organ, musculoskeletal, and urological applications. Contraindications: None stated.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• 7340 Esaote, S.p.A. (k081794 and k091009)
• SD5500 Aloka (k032875 and k033311)
• 4000 Aloka (k003739 and k040719)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Summary Model 7340 Upgrade Esaote, S.p.A.

K110688
Page 1 of 3

JUN - 2 2011

# 510(k) Summary

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

807.92(a)(1)

## Submitter Information

Esaote S.p.,A Via di caciolle 15 50127 Firenze Italy

| Contact Person: | Allison Scott<br>317.569.9500 x106<br>[e-mail] |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 7, 2011 |
| 807.92(a)(2) | |
| Trade Name: | Model 7340 upgrade |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulse Doppler imaging system 892.1550<br>Ultrasonic pulsed echo imaging system 892.1560<br>Diagnostic ultrasonic transducer 892.1570 |
| Classification Number: | 90IYN, 90IYO, 90ITX |
| 807.92(a)(3) | |
| Predicate Device(s) | |
| k081794 and k091009 | 7340 Esaote, S.p.A. |
| k032875 and k033311 | SD5500 Aloka |

k003739 and k040719

4000

Aloka

{1}------------------------------------------------

K1/0688
Page 2 of 3

510(k) Summary Model 7340 Upgrade Esaote, S.p.A.

## 807.92 (a)(4)

## Device Description

Model 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and onscreen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer. Model 7340 can be equipped with an internal battery that provides power when no main power is available.

The 7340 system has been cleared by FDA via k081794 and k091009.

Model 7340 upgrade, defined herein, combines the features of the Model 7340 with other, previously cleared software features and new software capabilities to assist a physician in making venous measurements. The venous imaging software package includes:

- 1) Dedicated Presets for Venous System Imaging, CFM and Doppler
- 2) QDP Quality Doppler Profiles Technology based on Multigate Doppler algorithm
- 3) Optimized Probe management for Venous Intracranial Doppler

The 7340 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

#### 807.92(a)(5)

## Intended Use(s)

Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-skeletal applications. The 7340 system provides imaging for venous system measurements.

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Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text includes the identifier "K110688" on the first line, followed by "Page 3 of 3" on the second line. The handwriting appears to be cursive and slightly slanted.

510(k) Summary Model 7340 Upgrade Esaote, S.p.A.

### 807.92(a)(6)

## Technological Characteristics

The 7340 model has been cleared via k081794 and k091009. The Aloka SD5500 system has been cleared via k032875 and k033311; the Aloka 4000 has been cleared via k003739 and k040719.

- · Clinical uses for which the 7340 is designed are not changed by the 7340 upgrade, to be cleared via this submission.
- · Clinical uses for which the Esaote 7340 and 7340 upgrade systems are designed are equivalent to those of the Aloka SD5500 ultrasound system, cleared via k032875 and k033311 and of the Aloks 4000 cleared via k k003739 and k040719.
- · Esaote 7340 and 7340 upgrade, the Aloka SD5500 and Aloka 4000 ultrasound systems are able to provide the profile of the flow of the vessels under exam. The Aloka SDS500 system has been cleared via k032875 and k033311; the Aloka 4000 has been cleared via k003739 and k040719.
- · Esaote 7340 and 7340 upgrade, Aloka SD5500 and Aloka 4000 ultrasound systems are designed to meet the IEC60601-1 and IEC60601-2-37.safety requirements.
- · Esaote 7340 and 7340 upgrade, Aloka SD5500 and Aloka 4000 ultrasound systems provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values. ******************************************************************************************************************************************************************************

## 807.92(b)(1)

## Non-Clinical Testing

Verification and validation tests have been conducted in accordance with design controls per CFR 820.30.

The system has been designed to meet the following standards:

- IEC 60601-1 .
- IEC 60601-1-2 ●
- IEC 60601-2-37 .
- ISO 10993-1 .
- AIUM/NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic � Ultrasound

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Esaote, S.p.A. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

JUN - 2 2011

Re: K110688

Trade/Device Name: 7340 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 17, 2011 Received: May 18, 2011

Dear Mr. Job:

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 7340 Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

| PA230 | LA523 | CA621 | TRT33 |
|-------|----------|-----------|--------|
| PA240 | LA532 | CA631 | TEE022 |
| PA121 | C5-2 R13 | 2 CW | TEE122 |
| PA122 | CA123 | 5CW | TEE132 |
| PA023 | CA421 | HF CW | IOE323 |
| LA332 | CA1421 | E8-5 R10P | LP323 |
| LA424 | CA430 | EC123 | BS230 |
| LA435 | CA431 | EC1123 | BC431 |
| LA522 | CA531 | BE1123 | BL433 |

{4}------------------------------------------------

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 895. 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 letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Joshua Nipper at [phone].

Sincerely Yours,

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

{5}------------------------------------------------

Indications for Use Statement

## Model 7340

## Indications for Use

510(k) Number (if known):

Device Name:

#### 7340 Ultrasound Systems

Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculo-Skeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-Skeletal applications. The 7340 system provides imaging for venous system flow profile.

Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patil

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110688

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

#### Mod.7340 upgrade

Intended use: Diagnostic uitrasound imaging or fluid flow analysis of human body as follows:

| Clinical Application | | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|---|--------------------|-----|-----|------------------|----------------------|-----------------|----------------------------------------|----------------------------------------|----------------------------------------|--|
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 7, 8, 9, 10, 13 | |
| Abdominal | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 7, 8, 9, 13 | |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 8, 9, 13 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 7, 8, 9, 13 | |
| Small Organ [1] | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 7, 8, 9, 13, 14 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 5, 6, 8, 9 | |
| Adult Cephalic | P | P | P | P | P | P | P | | P | P: 6, 8, 9; N: 15 | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P[16] | P: 4, 5, 6, 7, 8, 9, 11, 12 | |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | P: 4, 6, 9, 11, 12 | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 7, 8, 9, 13, 14 | |
| Transvaginal | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 9, 14 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 7, 8, 9, 10, 12, 13; N: 15 | |
| Laparoscopic | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 8, 9, 13 | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 7, 8, 9, 13, 14 | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 7, 8, 9, 13, 14 | |
| Other (Urological) | P | P | P | P | P | P | P | | P | P: 4, 5, 6, 7, 8, 9, 13 | |

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | 3D |
| [7] | 4D |
| [8] | VPan |
| [9] | XView |
| [10] | QIMT |
| [11] | Stress |
| [12] | Strain |
| [13] | TP View |
| [14] | ElaXto |
| [15] | Quality Doppler Profile (QDP) |

Mary Slostel

---

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110688

[16] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via k081794 and
k091009

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

| | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------------------|--------------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Tissue<br>Enhacement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | P: 6, 8, 9 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P | P: 6. 8, 9 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P[16] | P: 4, 6, 8, 9, 11,<br>12 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional (including<br>Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial (including<br>Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via k091009

| [1] | Small Organs includes Breast, Thyroid and Testicles | (Division<br>Division of Rad<br>Office of In Vitro Diagnostic<br>510K |
|------|-----------------------------------------------------|-----------------------------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric | |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD | |
| [4] | CMM | |
| [6] | 3D | |
| [8] | VPan | |
| [9] | XView | |
| [11] | Stress | |
| [12] | Strain | |

Mary Scott

Sign-Off) ological Devices Device Evaluation and Safety

K110688
510K

[16] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

| | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|----------------------------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | P: 8, 9 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P | P: 8, 9; N: 15 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P[16] | P: 4, 8, 9, 11, 12 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial (including<br>Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via k091009

| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|----------------------------------------------------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |
| [15] | Quality Doppler Profile (QDP) |
| [16] | Includes contrast (CnTi) in Adult Cardiac for left ventricle opacification and visualization |

of the left ventricular endocardial border

Mary Sfotel

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110688

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

| | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------------------|-----------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Tissue<br>Enhacement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | P: 8, 9 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | | P | P: 4, 8, 9, 11,<br>12 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via k091009

| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |

Mary S/otd

Division of Radiological Devices Office of In Vitro Diag Evaluation and Safety

510K K110688

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

| | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|----------------------------------------|--------------------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | P: 6, 8, 9 |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 6, 8, 9 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 4, 6, 8, 9, 11,<br>12 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 6, 8, 9, 12 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via k091009

| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [6] | 3D |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |

Strain

-
(12)

May S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluation and Safety

510K 110688

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

| | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------------------|--------------------|--|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Tissue<br>Enhacement<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | | P: 8, 9 | |
| Small Organ [1] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | | P: 8, 9 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac (2) | P | P | P | P | P | P | P | | | P: 4, 8, 9, 11, 12 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | | P: 8, 9 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via k091009

| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [8] | VPan |
| [9] | XView |
| [11] | Stress |
| [12] | Strain |

Division of Radiological Devices Office of In Vitro Diagnos aluation and Safety

510K K110C688

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

:

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

| Clinical Application | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|----------------------------------------|-------------------------------------|--|
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 4, 5, 6, 8, 9, 13 | |
| Small Organ [1] | P | P | P | | P | P | P | | P | P: 4, 5, 6, 8, 9, 13, 14 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 4, 5, 6, 8, 9, 10, 12, 13; N: 15 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | P: 4, 5, 6, 8, 9, 13 | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | P: 4, 5, 6, 8, 9, 13 | |
| Other (Urological) | | | | | | | | | | | |

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Previously cleared via k091009

| [1] | Small Organs includes Breast, Thyroid and Testicles | |
|------|-----------------------------------------------------|-----------|
| [2] | Cardiac is Adult and Pediatric | |
| [3] | Combined modes are: B + M + PW + CFM + PD | |
| [4] | CMM | |
| [5] | MView | |
| [6] | 3D | |
| [8] | VPan | |
| [9] | XView | |
| [10] | QIMT | |
| [12] | Strain | Office of |
| [13] | TP View | |
| [14] | ElaXto | 510K |
| [15] | Quality Doppler Profile (QDP) | |

Mary Stotl
(Division Sign-Off)

Division of Radiological Devices fice of In Vitro Diagnostic Devices
fice of In Vitro Diagnostic Device Evaluation and Safety

510K. K110688

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

| Clinical Application | Mode of Operations | | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|---------------------------------------|-----------------------------|--|
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Tissue<br>Enhacement<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,<br>13 | |
| Small Organ [1] | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,<br>13 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,<br>12, 13 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,<br>13 | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,<br>13 | |
| Other (Urological) | | | | | | | | | | | |

N: New indication; P: Previosuly cleared by FDA; E:Added under Appendix E

Strain

TP View

Previously cleared via k091009

(1)

(2)

[3]

(4)

ાંટો

រេរវា

। 1 ओ

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD CMM

MVicw

- ાંઠા 3D (8] VPan ત્વે XVicw
Mary S. Potter
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110688

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

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | Tissue<br>Velocity<br>Mapping<br>(TVM) | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|----------------------------------------|----------------------------------------|-----------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9, 13 |
| Small Organ [1] | P | P | P | | P | P | P | | | P: 4, 5, 6, 8, 9,<br>13, 14 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | |…