THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K103722 |
|---|---|
| Device Name | THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Medison Co., Ltd. |
| Product Code | ITX · Radiology |
| Decision Date | Jan 5, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The SONOACE R5 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, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult and Peripheral vessel.
Device Story
SONOACE R5 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays it in B-mode, M-mode, Color/Power Doppler, PW Spectral Doppler, Harmonic imaging, and Freehand 3D. Operated by healthcare professionals in clinical settings, the system provides anatomical measurements and analysis packages to assist in diagnosis. It features real-time acoustic output display (mechanical and thermal indices). Clinicians use the visual output to guide procedures like biopsies and assess anatomical structures or fluid flow. The device benefits patients by providing non-invasive diagnostic imaging for various clinical applications.
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, NEMA UD-2, NEMA UD-3, IEC 61157, and ISO 10993-1 for biocompatibility.
Technological Characteristics
Mobile diagnostic ultrasound system. Transducers: C2-4/20, C2-8, CN2-8, CN4-9, EC4-9, EVN4-9, LN5-12, LN5-12/40, L5-12/60. Modes: B, M, Color/Power Doppler, PW Doppler, Harmonic, 3D. Connectivity: Standard ultrasound I/O. Safety: IEC 60601-2-37, NEMA UD-2/UD-3. Biocompatibility: ISO 10993-1.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid analysis in fetal, abdominal, pediatric, small organ (e.g., thyroid, breast, scrotum, penis), neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional/superficial), adult cardiac, and peripheral vessel applications. Includes biopsy guidance and infertility monitoring.
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
- SONOACE R3 Diagnostic Ultrasound System (K101829)
- SONOACE R7 Diagnostic Ultrasound System (K102065)
Related Devices
- K101829 — THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jul 16, 2010
- K102065 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Aug 6, 2010
- K133505 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Dec 27, 2013
- K112646 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Oct 12, 2011
- K061213 — SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · May 16, 2006
Submission Summary (Full Text)
{0}------------------------------------------------
K103722
510(k) Premarket Notification
### SONOACE R5 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.
JAN - 5 2011
### 1. Submitter's Information: 21 CFR 807.92(a)(1)
MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea
Contact Person : Kyeong-Mi, Park Regulatory Affairs Manager
| Telephone: | 82.2.2194.1381 |
|------------|----------------|
| Facsimile: | 82.2.2194.1399 |
Data Prepared: July 2, 2010
### 2. Name of the device:
| Common/Usual Name: | Diagnostic Ultrasound System and Accessories | |
|------------------------------------------|----------------------------------------------|--------------|
| Proprietary Name: | SONOACE R5 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 |
#### 3. Identification of the predicate or legally marketed device:
K 101829, SONOACE R3 Diagnostic Ultrasound System K 102065, SONOACE R7 Diagnostic Ultrasound System
{1}------------------------------------------------
.
#### 4. Device Description:
The SONOACE R5 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, PW Spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes. The SONOACE RS 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 R5 has real time acoustic output display with two basic indices, a mechanical index, which are both automatically displaved.
The SONOACE R5 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
- 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
- IEC 61157, Declaration of the acoustic output
- ISO10993-1, Biocompatibility
#### 5. Intended Uses:
The SONOACE R5 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, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult and Peripheral vessel.
### 6. Technological Characteristics:
The SONOACE R5 is substantially equivalent to the SONOACE R3 Diagnostic Ultrasound System, cleared via K101829, and the SONOACE R7 Diagnostic Ultrasound System, cleared via K102065. 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
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features 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 seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1 394 25th Street NW BUFFALO MN 55313
JAN - 5 2011
Re: K103722
Trade/Device Name: SONOACE R5 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 20, 2010 Received: December 21, 2010
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 SONOACE R5 Diagnostic Ultrasound System, as described in your premarket notification:
### Transducer Model Number
| C2-4/20 | EVN4-9 |
|---------|-----------|
| C2-8 | LN5-12 |
| CN2-8 | LN5-12/40 |
| CN4-9 | L5-12/60 |
| EC4-9 | |
ﺎﻧﻪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟ
{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 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 (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 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 Paul Hardy at (301) 796-6542.
Sincerely yours,
h D Oh han
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
SONOACE R5 Diagnostic Ultrasound System
K103722
## SECTION 1.3 INDICATIONS FOR USE
- 5 2011 . I F N
510(k) Number (if known): K103722
SONOACE R5 Diagnostic Ultrasound System Device Name:
Indications for Use:
The SONOACE R5 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, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult and Peripheral-vessel.
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)
૨૧૦K
Michael D. Klein
Division of Radiological Devices valuation and Safety Office of In Vitro Diagnos
Section 1.3, page 1
{5}------------------------------------------------
510(k) No.:
| Device Name: SONOACE R5 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 | N | Note 1 | Notes 2,7,8 |
| | Abdominal | N | N | N | N | N | Note 1 | Notes 2,7,8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1 | Notes 2,5,6,7,8 |
| | Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2,5,6 |
| | Neonatal Cephalic | N | N | N | N | N | Note 1 | Notes 2,8 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | N | N | Note 1 | Note 2,7,8 |
| | Trans-vaginal | N | N | N | N | N | Note 1 | Note 2,7,8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2,5,6 |
| | Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2,5,6 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | Note 1 | Notes 4 |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2,5,6,8 |
| | Other (spec.) | | | | | | | |
N= new indication: I'= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler includes Power (Amplitude) Doppler
Note 1: B-M, B-PW, B+Color, B+Color+PW, B-Color+PW, B-PD+PW, B-Color+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, pediativ and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (Till)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Michael D. O'Kane
Section 1.3, page 2
(Division Siar Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103722
{6}------------------------------------------------
510(k) No .:
### Device Name: C2-4/20 for use with SONOACE R5
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 1 only) | Specific<br>(Tracks 1 & 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 |
| | Abdominal | P | P | P | | P | Note I | 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 2,5,7,8 |
| | 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 | P | P | P | | P | Note l | Notes 4 |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; It= previously cleared by FDA KI01829; E= added under Appendix E
Additional Comments:
.
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+Color, B+Color, B+PD, B+Color-PW, B=Color+Color+Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes inferility monitoring of follicle development
Note 4: Colur M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and nevolutions
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (TIII)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Division Sign
on of Radiological Devices Office of In
Section 1.3, page 3
Vitro Diagnostic Device Evaluation and Safety
510K K103722
{7}------------------------------------------------
510(k) No.:
Device Name: C2-8 for use with SONOACE R5
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 |
| | 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 2,5,7,8 |
| | Small Organ (See Note 3) | | | | | | | |
| | 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; I'= previously cleared by FDA KI01829; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitade) Doppler
Note 1: B-M, B-PW, B+Color, B+PD, B+Color+PW, B-PD+PW, B+Color-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, servium and penis in adult, pediativ and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (TIII)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
![]()
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic D Evaluation and Safety
510K K103222
{8}------------------------------------------------
510(k) No.:
### 'Device Name: CN2-8 for use with SONOACE R5
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 1 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 |
| | 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 2,5,7,8 |
| | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; I = previously cleared by FDA K101829; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B-M, B-PW, B+Color, B-PD, B-Color+PW, B-PD-PW, B-Color+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, serotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Hannonic Imaging (TIII)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OlVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
Marlon D. Johnson
(Division Sign Off)
Division of Radiological Devices Office of I
510K K103722
{9}------------------------------------------------
510(k) No .:
Device Name: CN4-9 for use with SONOACE R5
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 1 & 11) | 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 2,8 |
| | Small Organ ( <i>See Note 5</i> ) | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 2,8 |
| | 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 2,8 |
| | Other (spec.) | | | | | | | |
N= new indication: I = previously cleared by FDA K101829; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B-M, B-PW, B-Color, B+PD, B-Color+PW, B-PD-PW, B-Color-Color M
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, scrotum and penis in addl, pediatric and neonatul patients
Note 6: Abdominal organs and perspheral vessel
Note 7: Tissue Harmonic Imaging (1711)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
---
(Division Sign Off)
Section 1.3, page 6
(Division Sian-Off Division of Radiological Devices Office of Evaluation and Safety
510K K163,722
{10}------------------------------------------------
510(k) No.:
Device Name: EC4-9 for use with SONOACE R5
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 | | | | | | | |
| | 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 2,7,8 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2,7,8 |
| | 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: 12= previously cleared by FDA K101829; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I: B-M, B-PW, B+Color, B+PD, B+Color+PW, B+Color+Color M
Note 2: Includes imaging for gridance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color Manode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediativ and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (TIII)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
Mubl D DK
(Division Sign On
Division Sign-Off Division of Radiological Devices Office of Ir ice Evaluation and Safety
510K K103722
{11}------------------------------------------------
510(k) No.:
Device Name: EVN4-9 for use with SONOACE R5
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 | | | | | | | |
| | 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 | Notes 2,7,8 |
| | Trans-vaginal | N | N | N | | N | Note 1 | Notes 2,7,8 |
| | 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; I'= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B-M, B-PW, B+Color, B+PD, B-Color=PW, B+PD+PW, B-Color=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, pediativ and reonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Hammonic Imaging (TII)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
Michael D. Ott
(Division Sign-Off)
on of Radiological Devices Evaluation and Safety Office of In
Section 1.3, page 8
K103722
{12}------------------------------------------------
510(k) No.:
### Device Name: LN5-12 for use with SONOACE R5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| General<br>(Track I only) | Clinical Application<br>Specific<br>(Tracks 1 & II) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other<br>(Spec.) |
|---------------------------|-----------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note I | Notes 2,5,6 |
| | Small Organ (See Note 5) | N | N | N | | N | Note I | Notes 2,5,6 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | Note 1 | Notes 2,5,6 |
| | Musculo-skel. (Supertic.) | N | N | N | | N | Note I | Notes 2,5,6 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | Note I | Notes 5,6 |
| | Other (spec.) | | | | | | | |
N= new indication; I'= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplinde) Doppler
Note 1: B-M, B-PW, B+Color, B+PD, B-Color+PW, B-PD-PW, B+Color+Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertifity monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediativ and neonatul patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (TIII)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
(Division Sign-Off)
Division of Radiological Devices Office of In Vi lation and Safety
510K ท10322
{13}------------------------------------------------
510(k) No.:
Device Name: LN5-12/40 for use with SONOACE R5
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 | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2,5,6 | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Notes 2,5,6 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esuph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Notes 2,5,6 | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Notes 2,5,6 | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 5,6 | |
| | Other (spec.) | | | | | | | | |
N= new indication; P= previously cleared by FDA K101829; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: 13-M, B-PW, B+Color, B-PD, B-Color+PW, B-PD+PW, B+Color .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, pediatic and neonatal patients
Note 6: Abdominal organs and penpheral vessel
Note 7: Tissue Harmonic Imaging (TIII)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
Michal D Dik
Division Division of Radiolo Office of Ir aluation and Safety
510K K103722
{14}------------------------------------------------
| Clinical Application | | Mode of Operation (* includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|----------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note I | Notes 2,5,6 |
| | Small Organ (See Note 5) | P | P | P | | P | Note I | Notes 2,5,6 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note I | Notes 2,5,6 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note I | Notes 2,5,6 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note I | Notes 5,6 |
| | Other (spec.) | | | | | | | |
#### 510(k) No.: Device Name: L5-12/60 for use with SONOACE R5 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA K101829; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B-M, B-PW, B-Color, B+PD, B-Color+PW, B-PD+PW, B-Color -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 addl, pediativ and neonatal patients
Note 6: Abdominal organs and peripheral vesset
Note 7: Tissue Hannonic Imaging (FIII)
Note 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
M.hel D. O'h
(Division Sign Off)
(Division Sigr Division of Radiolog iation and Safety Office of In
510K. K103722
