MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM

K113381 · Samsung Medison Co., Ltd. · IYN · Dec 29, 2011 · Radiology

Device Facts

• Record ID: K113381
• Device Name: MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The MySono U6 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdonimal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Device Story

MySono U6 is a general-purpose, hand-held, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays it in various modes: B-mode, M-mode, Color/Power Doppler, PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, and 3D/4D imaging. Operated by healthcare professionals in clinical settings, the device allows for anatomical measurements and analysis packages to assist in diagnosis. It features real-time acoustic output display (mechanical and thermal indices). The system processes received echoes to generate on-screen images of structures and fluid flow. Output is used by clinicians to guide clinical decision-making, including biopsy guidance and infertility monitoring. Benefits include non-invasive visualization of internal structures and hemodynamics.

Clinical Evidence

Bench testing only. The device complies with safety standards including UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, IEC 60601-1-2, NEMA UD-2, NEMA UD-3, IEC 61157, and ISO 10993-1 for biocompatibility.

Technological Characteristics

Hand-held diagnostic ultrasound system. Sensing principle: ultrasonic pulsed echo/Doppler. Energy source: electrical. Connectivity: standard ultrasound system interfaces. Biocompatibility: ISO 10993-1 compliant. Software-controlled with real-time acoustic output display (mechanical/thermal indices).

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel applications. Patient population includes adult, pediatric, and neonatal patients.

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

• SONOACE R7 Diagnostic Ultrasound System (K112646)
• SONOACE X8 Diagnostic Ultrasound System (K093714)
• MySono U5 Diagnostic Ultrasound System (K100186)
• SONOACE R5 Diagnostic Ultrasound System (K103722)

Submission Summary (Full Text)

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DEC 2 9 2011

510(k) Premarket Notification

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

### 1. Submitter's Information: 21 CFR 807.92(a)(1)

SAMSUNG MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea

## Contact Person:

Kyeong-Mi, Park Regulatory Affairs Manager

| Telephone: | 82.2.2194.1373 |
|------------|----------------|
| Facsimile: | 82.2.556.9209 |

Data Prepared: October 10, 2011

### 2. Name of the device:

| Common/Usual Name: | | |
|----------------------------------------------|-----------|--------------|
| Diagnostic Ultrasound System and Accessories | | |
| Proprietary Name: | | |
| MySono U6 Diagnostic Ultrasound System | | |
| Classification Names: | FR Number | Product Code |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |

### 3. Identification of the predicate or legally marketed device:

- SONOACE R7 Diagnostic Ultrasound System (K112646) -
- SONOACE X8 Diagnostic Ultrasound System (K093714) -
- MySono U5 Diagnostic Ultrasound System (K100186) ﮯ
- SONOACE R5 Diagnostic Ultrasound System (K103722) .

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### 4. Device Description:

The MySono U6 is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The MySono U6 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The MySono U6 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The MySono U6 has been designed to meet the following product safety standards:

- UL 60601-1, Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- IEC60601-2-37, Diagnostic Ultrasound Safety Standards
- IEC60601-1, Safety requirements for Medical Equipment
- IEC60601-1-2, EMC requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output
- ISO10993-1, Biocompatibility

## 5. Intended Uses:

The MySono U6 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal, Abdonimal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

### 6. Technological Characteristics:

The MySono U6 is substantially equivalent with respect to safety, effectiveness, and functionality to the SONOACE R7 Diagnostic Ultrasound System (K112646), SONOACE X8 Diagnostic Ultrasound System (K093714) , MySono U5 Diagnostic Ultrasound System (K100186), and SONOACE R5 Diagnostic Ultrasound System (K103722).

All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

### END of 510(K) Summary

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a double helix, which is often associated with genetics and health. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

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

DEC 2 9 2011

Samsung Medison Co., Ltd. Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K113381

Trade/Device Name: MySono U6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 19, 2011 Received: December 20, 2011

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the DUS 6000 Digital Ultrasonic Imaging System, as described in your premarket notification:

### Transducer Model Number

| C2-5 | P2-4 |
|--------|--------|
| C2-8 | 3DC2-6 |
| C4-9 | 3D4-9 |
| EVN4-9 | CW2.0 |
| LN5-12 | |

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Michael O'Hara at [phone].

Sincerely Yours.

Mary S Pastel

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

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# SECTION 1.3 INDICATIONS FOR USE

510(k) Number (if known):

MySono U6 Diagnostic Ultrasound System Device Name:

Indications for Use:

The MySono U6 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasing and fluid analysis of the human body.

and The Harrysle of the Manage Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

1 Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Mary Stott

510K. K113381

Indications for Use

Section 1.3. page 1

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510(k) No.:

Device Name: MySono U6 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Clinical Application | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | N | N | N | | N | Note 1 | Notes 2, 4, 7, 8 |
| | Abdominal | N | N | N | N | N | Note I | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note I | Note 2, 5, 6, 7, 8 |
| | Small Organ (See Note 5) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8 |
| | Neonatal Cephalic | N | N | N | | N | Note 1 | Notes 8 |
| | Adult Cephalic | N | N | N | N | N | Note I | Note 7 |
| | Trans-rectal | N | N | N | | N | Note I | Note 2, 7, 8 |
| | Trans-vaginal | N | N | N | | N | Note 1 | Note 2, 7, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | Note I | Note 2, 5, 6, 7 |
| | Musculo-skel. (Superfic.) | N | N | N | | N | Note l | Note 2, 5, 6, 7 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note ! | Note 4, 7 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7.8 |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper Intrades Tover (Rapituale) Doppier, BiColor Doppler:PWD or CWD, BiPower Doppler/PWD, BiColor Dopple:/Color M Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrowm and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Mary Skstil

nd Safety

510K K113381

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510(k) No.:

Device Name: C2-5 for use with MySono U6

Dovice Name: 02 9 10 100 William of onaging or fluid flow analysis of the human body as follows:

| | Clinical Application | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8 |
| | Abdominal | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | |
| &<br>Other | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA K 112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper Instides Power (Ampiriate) Dopper
Note 1: B/M, B/Color M, B/PWD or CWD, B-Color Dopler, B/Color Dopler/PWD or CWD, B/Power Doppler/PWD, B Color Doppler/Color M Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Manu Patel

510K K113381

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510(k) No.:

Device Name: C2-8 for use with MySono U6

Device Name: C2-6 101 a30 with in Jours in on the move of the human body as follows:

| | Clinical Application | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8 |
| | Abdominal | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Supertic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA KI12646; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopler includes Power (Amplitude) Doppler, BiColor Doppler/PWD or CWD, B/Power Doppler/PWD, B/Color Doppler/Color M Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 4: For example: thyroid, breast, scrowm and penis in adult, pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Hannonic Imaging (THI)

Note 8: 3D imaging

Mary Sastid

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

610K K113381

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510(k) No.:

Device Name: C4-9 for use with MySono U6

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | N | N | N | | N | Note 1 | Notes 8 |
| | Abdominal | N | N | N | | N | Note 1 | Notes 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note 1 | Notes 8 |
| | Small Organ (See Note 5) | N | N | N | | N | Note 1 | Notes 8 |
| | Neonatal Cephalic | N | N | N | | N | Note 1 | Notes 8 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 8 |
| | Other (spec.) | | | | | | | |

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

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Doppier Intacts Forel (Anglaud) Doppler. B'Color Doppler:PWD or CWD, BrPower Doppler:PWD, BiColor Dopler: Color M Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Mary Sloth

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

510K K113381

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510(k) No.:

Device Name: EVN4-9 for use with MySono U6 Device Name: Every Totals will Information or fluid flow analysis of the human body as follows:

| Intended Use: Diagnostic Ultrasound Imaging of Fluid Flow Activity | | | | | | | | |
|--------------------------------------------------------------------|------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal linaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Notes 2, 8 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2. 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K103722; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopler includes Power (Amplitue) Doppler
Note ! : BM, B/Color M, B/PWD or CWD, B/Color Doppler, B/Color Doppler/PWD or CWD, B Power Doppler/Color M Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Hannonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

Mary S. Patil

Office of Ir iation and Safety

510K K113381

Section 1.3. page 6

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510(k) No.:

Device Name: LN5-12 for use with MySono U6

Dorroof Haner Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body, as follows:<br>Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal ( <i>See Note 3</i> ) | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2,5,6,7 | | |
| | Small Organ ( <i>See Note 5</i> ) | P | P | P | | P | Note 1 | Notes 2,5,6,7 | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Notes 2,5,6,7 | | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Notes 2,5,6,7 | | |
| | Intra-luminal | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 5,6,7 | | |
| | Other (spec.) | | | | | | | | | |

N= new indication; P= previously cleared by FDA K I ! 2646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopler includes Power (Amplitade) Dopper
Note I : B/M, B/Color M, B/PWD or CWD, B/Color Doppler, B/Color Doppler/PWD or CWD, B/Power Doppler/Color M Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Hannonic Imaging (THI)

Note 8: 3D imaging

Mary S. Postle
(Division Sign Off)

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

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

510(k) No.:

Device Name: P2-4 for use with MySono U6

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

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal | P | P | P | P | P | Note 1 | Note 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | Note 7 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K 100186; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopler Mataces Force Habpinater Boppler, BiColor Doppler:PWD or CWD, B:Power Doppler/PWD, B:Color Dopler/PWD, B:Color Dopler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Maru Shota
(Division Sign Off)

Division of Rediological Devic Office of In e Evaluation and Safety

510K K113381

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

510(k) No.:

Device Name: 3DC2-6 for use with MySono U6

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

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|---------------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal ( <i>See Note 3</i> ) | P | P | P | | P | Note 1 | Note 2, 4, 7, 8 |
| | Abdominal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Small Organ ( <i>See Note 5</i> ) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/Color M, B/PWD or CWD, B/Color Doppler:PWD or CWD, B/Power Doppler/PWD, B/Color Doppler/PWD, B/Color Doppier/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infectility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

Mary Shoots
(Division Sign-Off)

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

K113381

Section 1.3, page 9

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

510(k) No.:

Device Name: 3D4-9 for use with MySono U6

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

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & II) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | Note 1 | Note 2, 7, 8 | |
| | Trans-vaginal | N | N | N | | N | Note 1 | Note 2, 7, 8 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Supertic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | |

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

### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Doppict miciales Force (rangliade) Boppler, B Color Doppler:PWD or CWD, B Power Doppler:PWD, B Color Doppler:(Odor M

Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development

Note 3: Includes intensity monitoring
Note 4: Color M-mode

Note 4: Color M-mode

Note 1: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Hannonic Imaging (THI)

Note 8: 3D imaging

Macy S. Postel

Office of In

510K. K11338/

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

510(k) No.:

Device Name: CW2.0 for use with MySono U6

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

| Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body | | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
|--------------------------------------------------------------------------------------|-----------------------------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Clinical Application<br>Specific<br>(Tracks 1 & II) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | P | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | |
| | Cardiac Pediatric | | | | P | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K093714; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopler includes Power (Amplitude) Doppler
Note I: BiM, BiColor M, BiPWD or CWD, BiColor Dopler, B/Color Dopler/PWD or CWD, B/Power Doppler: Color M Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

Mary S. Pister

Office of In d Safety

510K K//338/

Section 1.3, page 11