MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100

K060827 · Esaote, S.p.A. · IYN · May 19, 2006 · Radiology

Device Facts

• Record ID: K060827
• Device Name: MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100
• Applicant: Esaote, S.p.A.
• Product Code: IYN · Radiology
• Decision Date: May 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Esaote's Model 7300 (MyLab30) is a compact 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. Esaote's Model 7350 (MyLab50) is a mainframe 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. Esaote's Model 6150 (MyLab70) is a mainframe 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. Esaote's Model 6100 (MyLab90) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Adult Cephalic, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.

Device Story

Ultrasound imaging systems (MyLab30, 50, 70, 90) perform diagnostic general ultrasound studies. Inputs: acoustic signals from phased, convex, linear array, and Doppler probes. Processing: B-Mode, M-Mode, Doppler, Color Flow Mapping, Tissue Enhancement Imaging (TEI), and 3D/4D image reconstruction. Outputs: real-time 2D/3D/4D images displayed on LCD monitor. Used in clinical settings by physicians/technicians for diagnostic assessment. Supports clinical decision-making through visualization of anatomy and blood flow. Benefits: non-invasive diagnostic imaging for various clinical applications including cardiac, abdominal, and musculoskeletal.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design similarity, performance testing of new transducers, and verification of 3D/4D imaging functionality against previously cleared predicate systems.

Technological Characteristics

Ultrasound imaging system; phased, convex, linear array, and Doppler probes; LCD color display; modes: B-Mode, M-Mode, Doppler, Color Flow Mapping, TEI, 3D/4D. Manufactured under ISO 9001:2000 and ISO 13485. Connectivity: standard ultrasound system interfaces.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including cardiac, vascular, abdominal, fetal, pediatric, small organ, musculoskeletal, and urologic applications. Intended for use by trained clinicians in clinical settings.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• 7300 (MyLab30) (K040596)
• 7350 (MyLab50) (K050326)
• 6150 (MyLab70) (K051308)
• 6100 (MyLab90) (K051837)
• 8000Live (K043455)
• Sequoia Signature II (K022567)

Submission Summary (Full Text)

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

K060827

WW 19

510(k) Summary MyLab30, 50, 70, 90 Systems Esaote, S.p.A.

# 510(k) Summary

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

807.92(a)(1)

## Submitter Information

Carri Graham, Official Correspondent The Anson Group 11460 N Meridian St., Ste 150 Carmel, Indiana 46032 Phone: [phone] x103 Facsimile: [phone]

| Contact Person: | Carri Graham |
|-------------------------|----------------------------------------------------------------------------------------------------|
| Date: | March 24, 2006 |
| 807.92(a)(2) | |
| Trade Name: | MyLab30, 50, 70, 90 Systems |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulse doppler imaging system 892.1550<br>Ultrasonic pulsed echo imaging system 892.1560 |
| Classification Number: | 90IYN; 90IYO |

807.92(a)(3)

# Predicate Device(s)

| K040596 | 7300 (MyLab30) | Esaote, S.p.A. |
|---------|----------------------|----------------|
| K050326 | 7350 (MyLab50) | Esaote, S.p.A. |
| K051308 | 6150 (MyLab70) | Esaote, S.p.A. |
| K051837 | 6100 (MyLab90) | Esaote, S.p.A. |
| K043455 | 8000Live | Medison |
| K022567 | Sequoia Signature II | Siemens |

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

510(k) Summary MyLab30, 50, 70, 90 Systems Esaote, S.p.A.

#### 807.92 (a)(4)

#### Device Description

The 7300 (MyLab30), 7350 (MyLab50), 6150 (MyLab70), and 6100 (MyLab90) system designs remain the same as those previously cleared by FDA via K040596, K050326, K051308, and K051837, respectively. They are ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.

The 30/50/70/90 systems are able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The systems in combination with the BC431 or BS230 probes, offer the possibility to also produce automatic 3D and Real Time 4D images. The 7300 (MyLab30), 7350 (MyLab50), 6150 (MyLab70), and 6100 (MyLab90) models are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

#### 807.92(a)(5)

#### Intended Use(s)

Esaote's Model 7300 (MyLab30) is a compact 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.

Esaote's Model 7350 (MyLab50) is a mainframe 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.

Esaote's Model 6150 (MyLab70) is a mainframe 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.

Esaote's Model 6100 (MyLab90) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Adult Cephalic, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.

{2}------------------------------------------------

ນວາຣໂຣ 06 ໂປຣ ໂດຣ ໂດຣ ໂດຣ ໂດຣ ໂດຣ ໂດຣຕະວັງລົງ
ເປັນນາ

# 9)(1) 26 Los

# ้นิยมาราชสาธิป โรวเรื่องโงแนวข

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:

| | To be added via this<br>510(k) | Siemens<br>Sequoia<br>Signature II<br>K022567<br>(Predicate) | Medison<br>8000Live<br>K043455<br>(Predicate) | Esaote<br>MyLab90<br>(6100)<br>K051837<br>(Predicate) | Esaote<br>MyLab70<br>(6150)<br>K051308<br>(Predicate) | Esaote<br>MyLab30CV<br>(7300)<br>K040596 | Esaote<br>MyLab50<br>(7350)<br>K050326 |
|----------------------|--------------------------------|--------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|------------------------------------------|----------------------------------------|
| 3D Mode | | | | <span style="text-align:center;">✔</span> | <span style="text-align:center;">✔</span> | YES | YES |
| 4D Mode | | | | <span style="text-align:center;">✔</span> | <span style="text-align:center;">✔</span> | YES | YES |
| Strain Rate | | | | YES | YES | YES | YES |
| Quantification | | | | YES | YES | YES | YES |
| Biopsy Accessories | | NO | NO | YES | YES | YES | YES |
| ABC43 | | NO | NO | YES | YES | YES | YES |
| Biopsy Kit for BS230 | | NO | NO | YES | YES | YES | YES |
| Transducers | | NO | NO | YES | YES | YES | YES |
| BC431 | | NO | NO | YES | YES | YES | YES |
| BS230 | | NO | NO | YES | YES | YES | YES |
| Indication For Use | | NO | NO | <span style="text-align:center;">✔</span> | <span style="text-align:center;">✔</span> | YES | YES |
| Urologic | | NO | NO | <span style="text-align:center;">✔</span> | <span style="text-align:center;">✔</span> | YES | YES |
| IMT.LAB Software* | | NO | NO | <span style="text-align:center;">✔</span> | <span style="text-align:center;">✔</span> | YES | YES |

ଦ mair indi tot betesh yfanoivang masala ada mari adi samani anda mani mari namin mari mari mari mari marka marin marin markasikan marin marin samani.
Mara munisa sida sinta ba

YES
NEST
* DIT

MISSION.

*IMT.LAB software was cleared via K043360 and runs on a stand-alone PC.

{3}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

**Public Health Service**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 9 2006

Esaote, S.p.A. % Ms. Carrie Graham Consultant Anson Group, LLC 11460 N Meridian St., Ste 150 CARMEL IN 46032

Re: K060827

Trade Name: MyLab30, 50, 70, 90 Systems 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: March 24, 2006 Received: March 27, 2006

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 Model 7300 (MyLab30) and 7350 (MyLab50) systems with the added BS230 and BC431 ultrasound transducers and the Model 6150 (MyLab70) and Model 6100 (MyLab90) systems with the added BC 431 ultrasound transducer.

Image /page/3/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular emblem with the letters "FDA" in the center, surrounded by the words "Centennial" and "1906-2006". Below the logo, the words "Protecting and Promoting Public Health" are written in a cursive font. The logo is black and white.

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

、それではないのです。 このため、 レートは、 イレーターの の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の の Page 2 - Ms. Graham

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Marvland 20850

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

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

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

Page 3 - Ms. Graham

All and the languan

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at [phone].

Sincerely yours,

Nancy C. Brogdon

**Nancy C. Brogdon**

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

くんなっており、お気になると、その他のお気になると、

Enclosure(s)

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

# Indications for Use

510(k) Number (if known): K 060827

MyLab30, 50, 70, 90 Systems addition of 3D/4D Device Name:

Indications For Use:

Esaote's Model 7300 (MyLab30) is a compact 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.

Esaote's Model 7350 (MyLab50) is a mainframe 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.

Esaote's Model 6150 (MyLab70) is a mainframe 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.

Esaote's Model 6100 (MyLab90) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Adult Cephalic, Laparoscopic, Intraoperative: Abdominal, and Other: Urologic.

Prescription Use X (Part 21 CFR 801 Subpart D) ANDIOR

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) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

Nancy C. broglon

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K060822 |

| | Page 1 of 1 |
|--|-------------|
|--|-------------|

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

一人人人人心在外国人人都会不得意了很多的意思想

かかりますとく、東京都道は開催してきたます。 東京都に、東京でするのですが、 さん

#### Model 7300 (MyLab30)

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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | P [2] | P [3], N[4] |
| Abdominal | | P | P | P | | P | P | | P [2] | P [3], N[4] |
| Intraoperative<br>(Abdominal) | | P | P | P | | P | P | | P [2] | P [3] |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P [2] | P [3], N[4] |
| Small Organ (specify) [1] | | P | P | P | P | P | P | | P [2] | P [3] |
| Neonatal Cephalic | | P | P | P | P | P | P | | P [2] | |
| Adult Cephalic | | P | P | P | P | P | P | | P [2] | |
| Cardiac | | P | P | P | P | P | P | | P [2] | P [3], N[4] |
| Transesophageal | | P | P | P | P | P | P | | P [2] | |
| Transrectal | | P | P | P | | P | P | | P [2] | |
| Transvaginal | | P | P | P | | P | P | | P [2] | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P [2] | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | P [2] | |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | P [2] | |
| Other (Urological) | | N | N | N | N | N | N | | N [2] | |

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

VPAN

- Tissue Velocity Mapping (TVM)
- CMM
- CnTI
- [4] 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)

Nancy C. Hogdon

(Division Sign-Off) Division of Reproduc and Radiological Device 510(k) Number

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

2017-12-12 17:00 PM 15-12-2017

#### Model 7350 (MyLab50)

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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | P [2] | P [3], N[4] |
| Abdominal | | P | P | P | | P | P | | P [2] | P [3], N[4] |
| Intraoperative<br>(Abdominal) | | P | P | P | | P | P | | P [2] | P [3] |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P [2] | P [3], N[4] |
| Small Organ (specify) [1] | | P | P | P | P | P | P | | P [2] | P [3] |
| Neonatal Cephalic | | P | P | P | P | P | P | | P [2] | |
| Adult Cephalic | | P | P | P | P | P | P | | P [2] | P [3] |
| Cardiac | | P | P | P | P | P | P | | P [2] | P [3], N[4] |
| Transesophageal | | P | P | P | P | P | | | P [2] | |
| Transrectal | | P | P | P | | P | P | | P [2] | |
| Transvaginal | | P | P | P | | P | P | | P [2] | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P [2] | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | P [2] | |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | P [2] | |
| Other (Urological) | | N | N | N | N | N | N | | N [2] | |

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 Harmonic Imaging (TEI)
CMM Tissue Velocity Mapping (TVM) VPAN Compound Imaging CnTI

[4] 3D/4D Imaging

and the may be and the state of the states of the section of

And And Andrews

1230 2012

#### (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 K060827

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

#### Model 6150 (MyLab70)

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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P [2] | P [3], N[4] |
| Abdominal | | P | P | P | P | P | P | | P [2] | P [3, N[4]] |
| Intraoperative<br>(Abdominal) | | P | P | P | P | P | P | | P [2] | P [3] |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P [2] | P [3], N[4] |
| Small Organ (specify) [1] | | P | P | P | P | P | P | | P [2] | P [3] |
| Neonatal Cephalic | | P | P | P | P | P | P | | P [2] | P [3] |
| Adult Cephalic | | P | P | P | P | P | P | | P [2] | P [3] |
| Cardiac | | P | P | P | P | P | P | | P [2] | P [3], N[4] |
| Transesophageal | | P | P | P | P | P | P | | P [2] | P [3] |
| Transrectal | | P | P | P | | P | P | | P [2] | P [3] |
| Transvaginal | | P | P | P | | P | P | | P [2] | P [3] |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P [2] | P [3] |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | P [2] | P [3] |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | P [2] | P [3] |
| Other (Urological) | | P | P | P | P | P | P | | P [2] | P [3] |

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 Harmonic Imaging (TEI)
- CMM

VPAN

Compound Imaging

CnTI

Tissue Velocity Mapping (TVM) 3D Imaging

[4] 4D Imaging

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

concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon
(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060827

16

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

A the may be the comments of the state of the states

## Model 6100 (MyLab90)

#### 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P [2] | P [3], N[4] | |
| Abdominal | | P | P | P | P | P | P | | P [2] | P [3], N[4] | |
| Intraoperative (Abdominal) | | P | P | P | P | P | P | | P [2] | P [3] | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P [2] | P [3], N[4] | |
| Small Organ (specify) [1] | | P | P | P | P | P | P | | P [2] | P [3] | |
| Neonatal Cephalic | | P | P | P | P | P | P | | P [2] | P [3] | |
| Adult Cephalic | | P | P | P | P | P | P | | P [2] | P [3] | |
| Cardiac | | P | P | P | P | P | P | | P [2] | P [3], N[4] | |
| Transesophageal | | P | P | P | P | P | P | | P [2] | P [3] | |
| Transrectal | | P | P | P | P | P | P | | P [2] | P [3] | |
| Transvaginal | | P | P | P | P | P | P | | P [2] | P [3] | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P [2] | P [3] | |
| Laparoscopic | | P | P | P | P | P | P | | P [2] | P [3] | |
| Muscolo-skeletal<br>Conventional | | P | P | P | P | P | P | | P [2] | P [3] | |
| Muscolo-skeletal<br>Superficial | | P | P | P | P | P | P | | P [2] | P [3] | |
| Other (Urological) | | P | P | P | P | P | P | | P [2] | P [3] | |

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 Harmonic Imaging (TEI)

CMM

VPAN

Compound Imaging

CnTI

Tissue Velocity Mapping (TVM)

3D Imaging

4] 4D Imaging

ripheral Vascular to include Vein Mapping & Scieroterapy

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEED concurrence of CDRH, Office of Device Evaluation (6

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 2060827

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

# 7300, 7350, 6150 and 6100 Systems

ਨ ਸੀ। ਕਿ ਕਿ ਕੀਤ

1000 1000

#### Mode of Operation Clinical Application Color Amplitude Color CWD PWD Combined Other A B M Doppler Doppler Velocity (PW) (CW) (specify) (specify) (CFM) (PD) Imaging Ophthalmic Fetal N N N N N N (1) N (2), NJ3) Abdominal N N N N N N (1) N (2), NJ3] Intraoperative (specify) Intraoperative Neurological Pediatric N N N N N N (1) N (2), N/3] Small Organ (specify) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethrai Intravascular Peripheral Vascular N N N N N N (1) N (2) Laparoscopic Muscolo-skeletal Conventional Muscolo-skeletal Superficial Other (Urological) N N N N N N (1) ਮ (2)

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And Articles

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

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

[2] Tissue Harmonic Imaging (TEI)

- CMM VPAN Compound Imaging CnTI Tissue Velocity Mapping (TVM) [3] 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)

Nancy C. brogdon

(Division Sign-Off)0
0
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 4060827

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

# 7300 and 7350 Systems

and and the other the same of the comments of the former of

| | 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), N[3] |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | ! | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | N | N | N | N | N | N | | N (1) | N (2), N[3] |
| Cardiac | | N | N | N | N | N | N | | N (1) | N (2), N[3] |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

BS230

Comment of the comments of the Children of the Market Home one

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 Harmonic Imaging (TEI)

Compound Imaging

CnTI

[3] 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)

Nancy C. hogdon

(Division Sign-Off) (Division Sign-Off, Only Division of Radiological Devices 510k) Number _

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

# 6150 and 6100 Systems

2012/04/2017 11:2

Auction of the

| | 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 | | P | P | P | P | P | P | | P (1) | P (2), N[3] |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | P (1) | P (2), N[3] |
| Cardiac | | P | P | P | P | P | P | | P (1) | P (2), N[3] |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

BS230

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 Harmonic Imaging (TEI)
- Compound Imaging
- CnTI
- 3D Imaging [3] 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)

Nancy C. Brogdon

(Division Sign-Off) (Division Sign-Only and Radiological Devices 510(k) Number _