SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K133505 |
|---|---|
| Device Name | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Samsung Medison Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Dec 27, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Device Story
SONOACE R7 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays it in various modes: B, M, Color/Power/Directional Power Doppler, PW/CW Spectral Doppler, Harmonic, Tissue Doppler, and 3D/4D imaging. Used in clinics by healthcare professionals for anatomical measurements and diagnostic analysis. Features include Quick Scan (Q Scan), Spatial Compound Imaging, Auto IMT+, Strain, Stress Echo, Panoramic, and Elastoscan. System provides real-time acoustic output display (mechanical/thermal indices). Output is viewed on-screen to assist clinicians in diagnosis and biopsy guidance. Benefits include non-invasive visualization of internal structures and fluid flow.
Clinical Evidence
Bench testing only. The device was evaluated for acoustic output, biocompatibility, and thermal, electrical, electromagnetic, and mechanical safety, conforming to standards including IEC 60601-1, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, and ISO 10993-1. No clinical data was required.
Technological Characteristics
Mobile diagnostic ultrasound system; 1.0-20.0 MHz transducer frequency range. Modes: B, M, PW/CW Doppler, Color/Power Doppler, Harmonic, 3D/4D. Features: Q Scan, Spatial Compound Imaging, Auto IMT+, Elastoscan. Patient contact materials tested to ISO 10993-1. Connectivity: Standard ultrasound I/O. Software-controlled. Sterilization: Transducers compatible with standard clinical disinfection protocols.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid analysis of the human body in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel applications. Prescription use only.
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)
- UGEO HM70A Diagnostic Ultrasound System (K130803)
- ACCUVIX A30 Diagnostic Ultrasound System (K112339)
- EKO 7 Diagnostic Ultrasound System (K101455)
- UGEO H60 Diagnostic Ultrasound System (K122583)
- UGEO PT60A Diagnostic Ultrasound System (K132228)
- MySono U6 Diagnostic Ultrasound System (K113381)
Related Devices
- K102065 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Aug 6, 2010
- K101829 — THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jul 16, 2010
- K103722 — THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jan 5, 2011
- K141620 — RS80A DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Jul 2, 2014
- K112646 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Oct 12, 2011
Submission Summary (Full Text)
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K133506
DEC 2 7 2013
510(k) Premarket Notification
SONOACE R7 Diagnostic Ultrasound System
## 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)
SAMSUNGMEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Contact Person: . Kyeong-Mi, Park
Regulatory Affairs Manager
| Telephone: | 82.2.2194.1373 |
|------------|----------------|
| Facsimile: | 82.2.556.3974 |
Data Prepared:September 9, 2013
### 2. Name of the device:
Common/Usual Name: Diagnostic Ultrasound System and Accessories Proprietary Name: SONOACE R7 Diagnostic Ultrasound System Product Code FR Number Classification Names: Ultrasonic Pulsed Doppler Imaging System 892.1550 IYN IYO Ultrasound Pulsed Echo Imaging System 892.1560 ITX 892.1570 Diagnostic Ultrasound Transducer
### 3. Identification of the predicate or legally marketed device:
- SONOACE R7 Diagnostic Ultrasound System(K112646) -
- UGEO HM70A Diagnostic Ultrasound System (K130803) -
- ACCUVIX A30 Diagnostic Ultrasound System(K112339) -
- EKO 7 Diagnostic Ultrasound System (K101455) .
- UGEO H60 Diagnostic Ultrasound System (K122583) -
- UGEO PT60A Diagnostic Ultrasound System (K132228) -
- MySono U6 Diagnostic Ultrasound System (K113381) ﮯ
- The proprietary names of predicate devices (K130803 / K122583) have been changed to UGEO HM70A / ※ UGEO H60 Diagnostic Ultrasound System from UGEO H70c / UGEO G60 Diagnostic Ultrasound System on FDA Databases.
510(k) Summary
Page 1 of 6
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### 4. Device Description:
The SONOACE R7 is a general purpose, mobile, 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(including Directional Power Doppler mode), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The SONOACE R7 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 SONOACE R7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
### 5. Intended Uses:
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial),Cardiac Adult, Cardiac Pediatricand Peripheral vessel.
### 6. Technological Characteristics:
The SONOACE R7is substantially equivalent with respect to safety, effectiveness, and functionality to the SONOACE R7 Diagnostic Ultrasound System (K112646) and ACCUVIX A30 Diagnostic Ultrasound System (K112339).
It is substantially equivalent with respect to safety, effectiveness, and functionality to the Bodymarker of SONOACE R7(K112646) in regards to the device with e-Motion Marker.
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.
These are described in detail in the technological characteristics comparison table as below.
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0NOACE R7 Diagnostic Ultrasound System
| Feature/Characteristics | The subject device<br>SONOACE R7 | SONOACE R7<br>(K112646) | ACCUVIX A30<br>(K112339) | EKO 7<br>(K101455) | UGEO HM70A<br>(K130803) | UGEO H60<br>(K122583) | MySono U6<br>(K113381) | UGEO PT60A<br>(K132228) |
|----------------------------------------------------|----------------------------------|-------------------------|--------------------------|--------------------|-------------------------|-----------------------|------------------------|-------------------------|
| Indication for Use | | | | | | | | |
| - Fetal | √ | √ | √ | √ | √ | √ | √ | √ |
| - Abdominal | √ | √ | √ | √ | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ | √ | √ | √ | √ |
| - Small Organ | √ | √ | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal<br>(Conventional) | √ | √ | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal<br>(Superficial) | √ | √ | √ | √ | √ | √ | √ | √ |
| - Cardiac Adult | √ | √ | √ | √ | √ | √ | √ | √ |
| - Cardiac Pediatric | √ | √ | √ | √ | √ | √ | √ | √ |
| - Peripheral vessel | √ | √ | √ | √ | √ | √ | √ | √ |
| Scanhead Types | | | | | | | | |
| - Linear Array | √ | √ | √ | √ | √ | √ | √ | √ |
| - Curved Linear Array | √ | √ | √ | √ | √ | √ | √ | √ |
| - Endocavity | √ | √ | √ | √ | √ | √ | √ | √ |
| - Phased Array | √ | √ | √ | √ | √ | √ | √ | √ |
| - Static Probes | √ | √ | √ | √ | √ | √ | √ | √ |
| Scanhead Frequency | | | | | | | | |
| - 1.0 - 20.0 MHz | √ | √ | √ | √ | √ | √ | √ | √ |
| Modes of Operation | | | | | | | | |
| - B-mode | √ | √ | √ | √ | √ | √ | √ | √ |
| - M-mode | √ | √ | √ | √ | √ | √ | √ | √ |
| - Pulsed wave (PW) Doppler | √ | √ | √ | √ | √ | √ | √ | √ |
| - Continuous wave (CW) Doppler | √ | √ | √ | √ | √ | √ | √ | √ |
| - Color Doppler | √ | √ | √ | √ | √ | √ | √ | √ |
| - Power Amplitude | √ | √ | √ | √ | √ | √ | √ | √ |
| Feature / Characteristics | The subject device<br>SONOACE R7 | SONOACE R7<br>(K112646) | ACCUVIX A30<br>(K112339) | EKO 7<br>(K101455) | UGEO HM70A<br>(K130803) | UGEO H60<br>(K122583) | MySono U6<br>(K113381) | UGEO PT60A<br>(K132228) |
| Doppler | √ | √ | √ | √ | √ | √ | √ | √ |
| Tissue Harmonic<br>Imaging | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D/4D imaging mode | √ | √ | √ | √ | √ | √ | √ | √ |
| Combined modes | √ | √ | √ | √ | √ | √ | √ | √ |
| Safety & EMC Compliance | | | | | | | | |
| IEC60601-1 | √ | √ | √ | √ | √ | √ | √ | √ |
| UL 60601-1 | | | | | | | | |
| CSA C22.2 No.601.1 | | | | | | | | |
| IEC 60601-2-37 | √ | √ | √ | √ | √ | √ | √ | √ |
| IEC 60601-1-2 | | | | | | | | |
| Acoustic Output Display Standard | √ | √ | √ | √ | √ | √ | √ | √ |
| Track 3 | | | | | | | | |
| Patient Contact Materials<br>tested to ISO 10993-1 | √ | √ | √ | √ | √ | √ | √ | √ |
| Functionality | | | | | | | | |
| Quick Scan (Q Scan) | √ | √ | √ | √ | √ | √ | √ | √ |
| Spatial Compound<br>Imaging | √ | √ | √ | √ | √ | √ | √ | √ |
| SMDR (Dynamic MR<br>Plus) | √ | √ | √ | √ | √ | √ | √ | √ |
| Auto IMT+(Auto IMT) | √ | √ | √ | √ | √ | √ | √ | √ |
| Strain | √ | √ | √ | √ | √ | √ | √ | √ |
| Stress Echo | √ | √ | √ | √ | √ | √ | √ | √ |
| Panoramic | √ | √ | √ | √ | √ | √ | √ | √ |
| Elastoscan | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D Imaging<br>(Volume Data<br>Acquisition) | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D Imaging presentation<br>(3D Cine/4D Cine) | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D Rendering | √ | √ | √ | √ | √ | √ | √ | √ |
| MPR(Multi Planer<br>Render) | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D XI | √ | √ | √ | √ | √ | √ | √ | √ |
fechnological Characteristics Comparison Table>
510(k) Summary
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:
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Page 3 of 6
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SONOACE R7 Diagnostic Ultrasound System
510(k) Summary
·
Page 4 of 6
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.
KONOACE R7 Diagnostic Ultrasound System
| Feature / Characteristics | The subject<br>device | The predicate devices | | | | | | |
|---------------------------|-----------------------|-------------------------|--------------------------|--------------------|-------------------------|-----------------------|------------------------|-------------------------|
| | SONOACE R7 | SONOACE R7<br>(K112646) | ACCUVIX A30<br>(K112339) | EKO 7<br>(K101455) | UGEO HM70A<br>(K130803) | UGEO H60<br>(K122583) | MySono U6<br>(K113381) | UGEO PT60A<br>(K132228) |
| MSV(Multi Slice View) | | V | V | V | V | V | V | V |
| Oblique View | | V | V | V | V | V | V | V |
| - 3D MagiCut | | V | V | V | V | V | V | V |
| - e-Motion Marker | | | | | | | | |
1) BodyMarker
510(k) Summary
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## 7. A brief discussion of the bench and non-clinical tests conducted on the subject device
The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.
The SONOACE R7 and its application comply with voluntary standards as below:
- 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
- EN/IEC60601-1,Safety requirements for Medical Equipment
- EN/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
- ISO10993-1, Biocompatibility
- ISO14971, Application of risk management to medical devices
Summary of Clinical Tests:
Not applicable. The subject of this submission, SONOACE R7, did not require clinical studies to support substantial equivalence.
### 8. Conclusion
Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the SONOACE R7to be as safe, as effective, and performanceis substantially equivalent to thepredicate devices.
END of 510(K) Summary
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2013
SAMSUNG MEDISON CO., LTD C/O MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL REGULATORY TECHNOLOGY SERVICES LLC 1394 25TH STREET NW BUFFALO MN 55313
Re: K133505
Trade/Device Name: SONOACE R7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 13, 2013 Received: November 14, 2013
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the SONOACE R7 Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model Number | | |
|-------------------------|------------|-------------|
| C2-5 | C2-8 | C4-9/10ED |
| ER4-9/10ED | EV4-9/10ED | L3-8 |
| L5-12/50EP | LN5-12 | HL5-12ED |
| P2-4AH | P3-7AC | 3DC2-6 |
| 3D4-8ET | 3D4-9ES | C4-9 |
| CF4-9 | ER4-9 | EVN4-9 |
| L5-12/50 | P2-4 | PN2-4 SP3-8 |
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| . | 3D4-8 | 3D4-9 | VN4-8 |
|---|-------|-------|-------|
| | | CW2.0 | |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
FDA
For
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
K133505
Device Name
SONOACE R7 Diagnostic Ultrasound System
Indications for Use (Describe)
The SONOACE R7 Diagnostic Ultrasound System and transcheers are intended for disgnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Trans-recal, Transvaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Pediatic and Peripheral vessel.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
# FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last pege.
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510(k) No.:
| Device Name: SONOACE R7 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.) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 |
| | Abdominal(See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12 |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 2,8, 9 |
| | Adult Cephalic | P | P | P | P | P | Note I | Note 4, 7 |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8, 11 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8, 11 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note I | Note 2, 5, 6, 7, 9, 12 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 12 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | Note I | Note 4, 7 |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note I | Note 4. 7 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 12 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power ( Amplitude) Doppler
Color Doppler includes Power (Amplinude) Dopler
Note I : B-M, B+PW, B+C, B+PD, B+CW, B+CW, B+C+PW, B+C+PW, B+DPD+PW, B+C+M, B+C+CW, B+PD+CW, B+PD-CW, Dual(B. B+C, B+PD, B+TD, B+PD)
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
Note 9; Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note I I : ElastoScan
Notel 2; Spatial Compound Imaging .
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
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. 510(k) Premarket Notification :
## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.:
Device Name: C2-5 for use with SONOACE R7 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) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9 | |
| | Abdominal(See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9 | |
| | 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<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared byFDA K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
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
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology Petvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801 109)
Indications for Use
{11}------------------------------------------------
#### ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
.
510(k) No.:
Device Name: C2-8 for use with SONOACE R7
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) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9 |
| | Abdominal(See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9 |
| | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared byFDA K112646; E= added under Appendix E
Additional Comments:
・
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
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 vesse!
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
{12}------------------------------------------------
510(k) No.:
Device Name: C4-9/10ED for use with SONOACE R7 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) | P | P | P | P | P | Note 1 | Notes 2,8, 9 |
| | Abdominal(See Note 10) | P | P | P | P | P | Note 1 | Notes 2,8, 9 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Notes 2,8, 9 |
| | Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Notes 2,8, 9 |
| | Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 2,8, 9 |
| | 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 | P | Note 1 | Notes 2,8, 9 |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared byFDA K112646; E= added under Appendix E
. Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Collar Dopper Interest one ( milipinate) Dopper
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+C+PW, B+PD+PW, B+C+M, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color Momode
Note 5: For example: thyroid, parathyroid, breast, serotum 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
.
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
{13}------------------------------------------------
510(k) No .:
Device Name: ER4-9/10ED for use with SONOACE R7 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) | P | P | P | | P | Note 1 | Notes 2, 8 |
| | Abdominal(See Note 10) | P | P | P | | P | Note 1 | Notes 2, 8 |
| | 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 | 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 K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Nate I: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+TD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
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, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis Note 11: ElastoScan
Note 12: Spatial Compound Imaging
#### Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
. -
{14}------------------------------------------------
510(k) No .:
.
Device Name: EV4-9/10ED for use with SONOACE R7 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 | Notes 2, 8 |
| | Abdominal ( <i>See Note 10</i> ) | P | P | P | | P | Note 1 | Notes 2, 8 |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ ( <i>See Note 5</i> ) | | | | | | | |
| | 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 | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication: P= previously cleared by FDAK112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Dopper Mellaus Front (Timpinson Boppia
Note 1: B+M, B+C+PD, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
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
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
{15}------------------------------------------------
510(k) No.:
Device Name: L3-8 for use with SONOACE R7
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> ) | | | | | | | | |
| | Abdominal ( <i>See Note 10</i> ) | | | | | | | | |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | Note I | Note 2, 5, 6, 7, 9, 12 | |
| | Small Organ ( <i>See Note 5</i> ) | N | N | N | | N | Note I | Note 2, 5, 6, 7, 9, 12 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 9, 12 | |
| | Musculo-skel. (Superfic.) | N | N | N | | N | Note 1 | Note 2. 5, 6. 7, 9, 12 | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | Note I | Note 2, 5, 6, 7, 9, 12 | |
| | 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+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
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
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801 109)
Indications for Use
{16}------------------------------------------------
510(k) No .:
Device Name: L5-12/50EP for use with SONOACE R7 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(See Note 10) | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 12 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 12 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 12 |
| | Musculo-skel. (Superfic.) | P | P | P | - | P | Note 1 | Note 2, 5, 6, 7, 9, 12 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) |…
