ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO

K061641 · Shimadzu Medical Systems · IYO · Jul 14, 2006 · Radiology

Device Facts

• Record ID: K061641
• Device Name: ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
• Applicant: Shimadzu Medical Systems
• Product Code: IYO · Radiology
• Decision Date: Jul 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The sarano is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

Device Story

The sarano is a mobile diagnostic ultrasound system utilizing flat linear array and convex linear transducers with a frequency range of 2-15 MHz. It operates in B-mode, M-mode, or combinations thereof to provide diagnostic imaging. The system is intended for use by healthcare professionals in clinical settings to visualize internal structures and blood flow. Output is displayed on the system monitor for clinician interpretation to support diagnostic decision-making. The device benefits patients by providing non-invasive, real-time diagnostic imaging for various clinical applications.

Clinical Evidence

Bench testing only. The device complies with IEC 60601-1 safety standards and AIUM/NEMA acoustic output measurement and labeling standards (UD2, UD3). No clinical data was required for this clearance.

Technological Characteristics

Mobile ultrasound system; frequency range 2-15 MHz; transducers include flat linear array and convex linear types; modes: B, M, and combined; complies with IEC 60601-1, AIUM NEMA UD2, and AIUM NEMA UD3 standards.

Indications for Use

Indicated for diagnostic ultrasound imaging or Doppler analysis of the human body, including fetal, abdominal, pediatric, small organ (thyroid, testicles, breast), neonatal/adult cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional/superficial) applications.

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

• Shimadzu Corporation SDU-1100 (K050510)

Submission Summary (Full Text)

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

# KD61641

JUL 1 4 2006

#### 510(k) Summary

#### 1.0 SUBMITTER INFORMATION

1.1 Submitter: SHIMADZU MEDICAL SYSTEMS 20101 South Vermont Ave. Torrance, CA 90502-1328 PH: 310-217-8855 FX: 310-217-8869

1.2 Contact: Randal Walker

- 1.3 Date: March 31, 2006
#### 2.0 DEVICE NAME

| 2.1 Proprietary Name: | sarano |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.2 Common Name: | Ultrasound Imaging System |
| 2.3 Classification: | Ultrasonic Pulsed Echo Imaging System<br>FR # 892.1560, Product Code 90-IYO<br>Diagnostic Ultrasound Transducer<br>FR # 892.1570, Product Code 90-ITX |
| 2.4 Predicate Device: | Shimadzu Corporation SDU-1100 (K050510, 4/1/05) |

#### 3.0 DEVICE DESCRIPTION

The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes.

#### 4.0 INTENDED USE

The sarano is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

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

## 5.0 SAFETY CONSIDERATIONS

The sarano has been designed to meet the following voluntary and measurement standards:

- . IEC 60601-1 Safety of Medical Electric Equipment
- AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound Equipment
- Acoustic Output Measurement and Labeling Standard for Diagnostic . Ultrasound Equipment Revision 1 (AIUM 1998)
- AIUM NEMA UD3 Standard for Real-time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

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

Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

JUL 1 4 2006

Mr. Randal Walker National Service Manager Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328

Re: K061641

Trade Name: EchoView/Shimasonic Diagnostic Ultrasound System - sarano 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: Dated: May 12, 2006 Received: June 13, 2006

#### Dear Mr. Walker:

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 sarano Diagnostic Ultrasound System, as described in your premarket notification:

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

### Transducer Model Number

| L040-120HU | VA40R-035U | L072-050U |
|------------|--------------|-------------|
| L040-100U | VA57R-0375WU | VA20R-035U |
| L070-075U | TV11R-055U | VA57R-0375U |
| VA11R-055U | EC11R-055U | |
| VA13R-035U | UB10R-065U | |

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, 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.

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

Page 2 - Mr. Walker

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 Andrew Kang, M.D. at [phone].

Sincerely yours,

David A. Legum

for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

Ultrasound Device Indications Statement

Page _ 1 _ of __ 13

KOGI64 510(k) Number (if known) : Device Name : Diagnostic Ultrasound System sarano, system

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | นับบัง ประเทศเมน<br>Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|--------------------------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | N | N | | | | | | N | N | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | N | N | | | | | | N | N | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | | | | | | N | N | |
| Transvaginal | | N | N | | | | | | N | N | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | | | | | | N | N | |
| Musculo-skeletal<br>Superficial | | N | N | | | | | | N | N | |
| Other (Specify) | | | | | | | | | | | |

Mode of Oneration

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

Other Indications or Modes:

* Thyroid. Testicles. Breast ** В/М

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

David A. Degnan

11 Fridarrating 2

K06641

Prescription Use

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

Ultrasound Device Indications Statement

Page _2 _ of _ 14

K061641 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System sarano. L040-120HU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | N | N | | | | | | N | N | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | | | | | | N | N | |
| Musculo-skeletal<br>Superficial | | N | N | | | | | | N | N | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

- Thyroid. Testicles. Breast

** B/M

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

Daniel A. Lygonn

val.

K061641

Prescription Use

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

Ultrasound Device Indications Statement

Page _ 3 of _ 14

510(k) Number (if known): K061641.
Device Name: Diagnostic Ultrasound System sarano, L040-100U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmoni<br>c<br>Imaging | Other<br>(Specify) |
|----------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-----------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| (Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | N | N | | | | | | N | N | |
| (Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | N | N | | | | | | N | N | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal | | N | N | | | | | | N | N | |
| Superficial | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

| LA-AL-A-MILL-A-A-<br>STATE A-1-1-1-1-11-1<br>I<br>S<br>No. 000<br>E<br>1<br>11. 8. 1 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1<br>00110 00<br>14/5/11<br>1 1 2 1 1 1 1 1 1<br>ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ<br>146-48-4<br>11-4-4-4-80000 -1-41-40-4-4-4 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>I<br>. |
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David Ch. Leggeem

Abdominal,
K061641

Prescription Else

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

Page ___ of Ultrasound Device Indications Statement

510(k) Number (if known): K061641

910(tr) Name : Diagnostic Ultrasound System sarano. L070-075U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | N | N | | | | | | N | N | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | | | | | | N | N | |
| Musculo-skeletal<br>Superficial | | N | N | | | | | | N | N | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

14

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

Other Indications or Modes:

- Thyroid, Testicles, Breast

** B/M

David h. Syomm

Abdominal

K061641

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

Ultrasound Device Indications Statement Page 5 of 14

510(k) Number (if known): k061641.

Device Name : Diagnostic Ultrasound stem sarano. VA11R-055U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | N | N | | | | | | N | N | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

** B/M

David A. Lepore

Teproductive, Abdominal,

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

Ultrasound Device Indications Statement Page 6 of _14

510(k) Number (if known) : K061641

Device Name : Diagnostic Ultrasound VA13R-035U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | N | N | | | | | | N | N | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

**B/M**

David A. Ingram

Reproductive, Abdon

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
|-------------------------|-------------------------|

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

Ultrasound Device Indications Statement

Page _ 7 of _ 14

510(k) Number (if known): `<061641.

Device Name : Diagnostic Ultrasound System sarano. VA40R-035U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | N | N | | | | | | N | N | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

** B/M

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

... .........

David A. Ingram

ture, Abdominal.

KD61641

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

Ultrasound Device Indications Statement

Page _ 8 of 14

510(k) Number (if known): K061641.
Device Name: Diagnostic Ultrasound System sarano. VA57R-0375WU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | N | N | | | | | | N | N | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Onemation

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

Other Indications or Modes:

**B/M

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

David the. Seym

of Heproductive, Abdominal,

Devices
KD6164

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

Ultrasound Device Indications Statement Page 9 of 14

510(k) Number (if known) : K061641.

Device Name : Diagnostic Ultrasound System sarano. TV11R-055U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | | | | | | N | N | |
| Transvaginal | | N | N | | | | | | N | N | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

**B/M

David A. Segram

Abdominal,
K0664

.

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

Ultrasound Device Indications Statement

Page _ 10_ of _14

510(k) Number (if known) : K061641.

Device Name : Diagnostic Ultrasound System sarano. EC11R-055U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | N | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | | | | | | N | N | |
| Transvaginal | | N | N | | | | | | N | N | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

** B/M

David R. Sycamore

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

Ultrasound Device Indications Statement

Page _ 1 l of 14

510(k) Number (if known): K061641

Device Name : Diagnostic Ultrasound System sarano, UB10R-065U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify)* | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | N | N | | | | | | N | N | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

**B/M

Daniel A. Degnan

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

Ultrasound Device Indications Statement

Page _12_of _ 14

510(k) Number (if known): k061641

Device Name : Diagnostic Ultrasound System sarano. L072-050U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

| Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | N | N | | | | | | N | N | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | | N | N | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | | | | | | N | N | |
| Musculo…