DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC

K082224 · Shimadzu Medical Systems · ITX · Dec 15, 2008 · Radiology

Device Facts

• Record ID: K082224
• Device Name: DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
• Applicant: Shimadzu Medical Systems
• Product Code: ITX · Radiology
• Decision Date: Dec 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• 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, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

Device Story

The sarano is a mobile diagnostic ultrasound system utilizing flat linear array and convex transducers (2-15 MHz). It operates in B-mode, M-mode, or combined modes to provide diagnostic imaging. The system features either a standard CRT or optional LCD monitor. It is intended for use by clinicians in clinical settings to perform ultrasound imaging or Doppler analysis across various anatomical applications. The device aids in clinical decision-making by providing real-time visual diagnostic information to healthcare providers, potentially benefiting patients through non-invasive assessment of internal structures and vascular conditions.

Clinical Evidence

Bench testing only. The device complies with IEC 60601-1, UL60601-1:2003, and AIUM/NEMA UD2/UD3 standards for acoustic output measurement and safety.

Technological Characteristics

Mobile ultrasound system; flat linear array and convex transducers (2-15 MHz); B-mode, M-mode, and combined modes; CRT or LCD monitor; complies with IEC 60601-1, UL60601-1, and AIUM/NEMA UD2/UD3 standards.

Indications for Use

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

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Shimadzu Corporation sarano (K061641)

Submission Summary (Full Text)

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

Koszzy

# " DEC 1 5 2008

#### 510(k) Summary

#### 1.0 SUBMITTER INFORMATION

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

1.2 Contact: Don Karle

July 23, 2008 1.3 Date:

#### 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 sarano (K061641, Jul 14. 2006) |

#### 3.0 DEVICE DESCRIPTION

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

Also the sarano has two kinds of monitor; CRT and LCD. The former is standard model and latter is optional model.

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

#### 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, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

#### 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 t
- UL60601-1:2003 Medical Electrical Equipment Part I : General . Requirements for Safety
- 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}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Don Karle Customer Service Manager Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328

### DEC 1 5 2008

Re: K082224

Trade/Device Name: Diagnostic Ultrasound System sarano, system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: July 23, 2008 Received: September 22, 2008

Dear Mr. Karle:

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

#### Transducer Model Number

L040-120HU L040-100U L070-075U VA11R-055U VA13R-035U

VA40R-035U VA57R-0375WU TV11R-055U EC11R-055U UB10R-065U

L072-050U VA20R-035U VA57R-0375U VA57R-0375SU

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

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 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

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

**Sincerely yours,**

Hhuleen
Joyce M. Whang, Ph.D.

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

Enclosure(s)

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

Ultrasound Device Indications Statement

Page _1 _of_15

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:

| 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 | | P | P | | | | | | P | P | |
| Abdominal | | P | P | | | | | | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | P | P | | | | | | P | P | |
| Neonatal<br>Cephalic | | N | N | | | | | | N | N | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | | | | | | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | | | | | | P | P | |
| Transvaginal | | P | P | | | | | | P | P | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | | | | | | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | | | | | | P | P | |
| Musculo-skeletal<br>Superficial | | P | P | | | | | | P | P | |
| Other (Specify) | | | | | | | | | | | |

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 Evalustion (ODE)

Hald Reen

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

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

Ultrasound Device Indications Statement Page 2_of_15

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

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:

| 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) * | | P | P | | | | | | P | P | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | | | | | | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | | | | | | P | P | |
| Musculo-skeletal<br>Superficial | | P | P | | | | | | P | P | |
| 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 NBEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulst

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

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

Ultrasound Device Indications Statement

Page 3 of 15

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:

..

| 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>Harmoni<br>c<br>Imaging | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | P | P | | | | | | P | P | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | P | P | | | | | | P | P | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | | | | | | P | P | | |
| Musculo-skeletal<br>Superficial | | P | P | | | | | | P | P | | |
| Other (Specify) | | | | | | | | | | | | |

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) currence 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

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

Ultrasound Device Indications Statement Page 4 _of 15

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

Device 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:

| 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) * | | P | P | | | | | | P | P | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | | | | | | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | | | | | | P | P | |
| Musculo-skeletal<br>Superficial | | P | P | | | | | | P | P | |
| Others (Specify) | | | | | | | | | | | |

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)

Hhberteem

Prescription Use (Per 21 CFR 801.109)

(Division Siyn-Uft) Division of Reproductive. Abdominal and Radiological Device: 510(k) Number

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

Ultrasound Device Indications Statement

Page - 5 __ of ાં ર

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System 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:

ﺴﺮ ﺳﺮ

| 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 | | P | P | | | | | | P | P | |
| Abdominal | | P | P | | | | | | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | N | N | | | | | | N | N | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | | | | | | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

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 LINB-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

H

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

"-- cription Use cr 21 CFR 801.109)

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

Ultrasound Device Indications Statement

Page _6__ of _ 15

510(k) Number (if known) : _K061641.

:

Device Name : Diagnostic Ultrasound System sarano, VA 13R-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:

| | | | | | | 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 | | P | P | | | | | | P | P | | | |
| Abdominal | P | P | P | | | | | | P | P | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | P | P | | | | | | P | P | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | | | |

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)

| (Division Sign-Off) | |
|--------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K082224 |

| | Prescription Use<br>(Per 21 CFR 801.109) |
|--|------------------------------------------|
|--|------------------------------------------|

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

#### Ultrasound Device Indications Statement Page _ 7 _ of _ 15

510(k) Number (if known) : K061641

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:

| Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| 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 | | P | P | | | | | | P | P | |
| Abdominal | P | P | P | | | | | | P | P | |
| 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) | | | | | | | | | | | |

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

Other Indications or Modes:

**B/M**

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

Halb Leun
__
(Division Sign-Off)

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

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

#### Ultrasound Device Indications Statement

Page 8 of 15

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:

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

| Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| 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 | P | P | P | | | | | | P | P | |
| Abdominal | P | P | P | | | | | | P | P | |
| 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<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

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) Cancurrence of CDRH, Office of Device Evaluation (ODE)

Hhlem

---

Division Sign Off)

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

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

Ultrasound Device Indications Statement

Page_9_of_15

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 | | P | P | | | | | | P | P | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | P | P | | | | | | P | P | | |
| Transvaginal | | P | P | | | | | | P | P | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Others (Specify) | - | | | | | | | | | | | |

.

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

**Other Indications or Modes:**

Radiological Devices 510(k) Number

**B/M**

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

(Division Sign-Off)
Prescription Use
(Per 21 CFR 801.109)
Division of Reproductive, Abdominal and

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

Ultrasound Device Indications Statement

Page 10 of 15

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 | | P | P | | | | | | P | P | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | | | | | | P | P | |
| Transvaginal | | P | P | | | | | | P | P | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Oneration

No 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 NERDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Helles

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

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

Ultrasound Device Indications Statement

Page 11 of 15

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:

| 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) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | | | | | | P | P | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

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

Other Indications or Modes:

** ВМ

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

Helo

---

(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082224

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

Ultrasound Device Indications Statement

Page 12 of 15

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) * | | P | P | | | | | | P | P | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | | | | | | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | | | | | | P | P | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

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

Other Indications or Modes:

* Thyroid, Testicles, Breast

**B/M**

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

Heleen

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082224

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

Ultrasound Device Indications Statement

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

Device Name : Diagnostic Ultrasound System sarano, VA20R-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:

Page _13_of _15

| 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 | | | | | | | | | |…