(15 days)
The SONOACE R3 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.
The SONOACE R3 is a general purpose, portable, 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, Freehand 3D imaging mode or as a combination of these modes. The SONOACE R3 also gives the operator the ability to measure annomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R3 has real time acoustic output display with two basic indices, a mechanical index and a thermised index, which are both automatically displayed.
The provided text describes the SONOACE R3 Diagnostic Ultrasound System and its intended uses, primarily focusing on general safety and function. It states that the device is "substantially equivalent" to predicate devices (SONOACE X6 and SONOACE PICO) and lists various safety and acoustic output standards it meets.
However, the provided text does not contain any information about a study proving the device meets specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) related to its diagnostic capabilities, nor does it include information about AI/algorithm performance.
The tables detailing clinical applications and modes of operation for the main system and specific transducers (C2-4/20, CN2-8, CN4-9, EC4-9, L5-12/60, LN5-12/40) merely indicate which applications each can be used for ("N" for new indication, "P" for previously cleared). This is about intended use, not performance metrics or acceptance criteria for diagnostic efficacy.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance studies, which are not detailed here.
Here's a breakdown of what can be extracted, and what is missing:
Information from the document:
- 1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (General): The device has been designed to meet several product safety standards (UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2, NEMA UD-2, NEMA UD-3, IEC 61157, ISO10993-1). These are primarily safety and technical performance standards, not diagnostic performance metrics.
- Reported Device Performance: The document states the device is "substantially equivalent" to predicate devices (K081676, SONOACE X6 Diagnostic Ultrasound System; K061213, SONOACE PICO Diagnostic Ultrasound System). This means its performance is considered equivalent to these previously cleared devices, but no specific performance metrics like sensitivity, specificity, or accuracy are provided.
- 2. Sample size used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. There is no indication of AI or human reader studies.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. There is no indication of an algorithm or AI.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
- 8. The sample size for the training set: Not mentioned. (Not applicable as no AI/algorithm is described).
- 9. How the ground truth for the training set was established: Not mentioned. (Not applicable as no AI/algorithm is described).
Missing Information (and why it's missing from this document):
The provided document is a 510(k) Premarket Notification summary for a diagnostic ultrasound system. For devices like this, especially back in 2010, the primary focus of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical performance studies with detailed statistical metrics, ground truth establishment, or AI algorithm validation. The "acceptance criteria" here are mainly about meeting recognized safety and functional standards, and the "study" is the demonstration of substantial equivalence in form and function.
For AI-enabled medical devices, clinical performance studies with the requested details (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) would typically be required in a more recent submission, and would be a separate, much more detailed section of the regulatory filing. This document predates the common inclusion of such detailed AI performance data in 510(k) summaries.
{0}------------------------------------------------
JUL 16 2010
6101829
510(k) Premarket Notification
SONOACE R3 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 FR 807.92(a)(1)
MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea
Contact Person: Mr. Kyung-Am, Shim Regulatory Affairs Manager
Telephone: 82.2.2194.1381 Facsimile: 82.2.2194.1399
Data Prepared: April 6, 2010
2. Name of the device:
| Common/Usual Name: | ||
|---|---|---|
| Diagnostic Ultrasound System and Accessories | ||
| Proprietary Name: | ||
| SONOACE R3 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:
K081676, SONOACE X6 Diagnostic Ultrasound System K061213, SONOACE PICO Diagnostic Ultrasound System
510(k) Summary / Statement Certification
ATTACHMENT 1
{1}------------------------------------------------
4. Device Description:
The SONOACE R3 is a general purpose, portable, 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, Freehand 3D imaging mode or as a combination of these modes. The SONOACE R3 also gives the operator the ability to measure annomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R3 has real time acoustic output display with two basic indices, a mechanical index and a thermised index, which are both automatically displayed.
The SONOACE R3 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 R3 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.
Technological Characteristics: 6.
The SONOACE R3 is substantially equivalent to the SONOACE X6 Diagnostic Ultrasound System, cleared via K081676, and the SONOACE PICO Diagnostic Ultrasound System, cleared via K061213. All systems transmit ultrasonic encry 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
510(k) Summary / Statement Certification
ATTACHMENT 1
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 1 3 2010
Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K101829
Trade/Device Name: SONOACE R3 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: June 30, 2010 Received: July 1, 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 SQNOACE R3 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C2-4/20 | EC4-9 |
|---|---|
| CN2-8 | L5-12/60 |
| CN4-9 | LN5-12/40 |
{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/CDRH0ffices/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 vours.
Maha D. O'Brien for
Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
510(k) Premarket Notification
SONOACE R3 Diagnostic Ultrasound System
Indications for Use
510(k) Number (if known):
Device Name: SONOACE R3 Diagnostic Ultrasound System
Indications for Use:
The SONOACE R3 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)
Division Sign-Off
Division of Radiological Device Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101829
Page 1 of 12
Indications For Use
.
{5}------------------------------------------------
510(k) Premarket Notification
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No .:
Device Name: SONOACE R3 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(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(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& 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 | Cardiac Adult | N | N | N | N | N | Note 1 | Notes 4 |
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2,5,6,8 |
| Other (spec.) |
N= new indication; P= 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
510
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 8: 3D imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Indications For Use
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{6}------------------------------------------------
510(k) No.:
Device Name: C2-4/20 for use with SONOACE R3
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(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(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& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | 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 | N | N | N | N | N | Note 1 | Notes 4 | |
| 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
Note 1: B+M, B+PW, B+Color, B+PD, B+Color+PW, B+PD+PW, B+Color+Color M
510k
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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Indications For Use .
(Division Sign-Off) Division of Radiological Devices Division of Radiological Bovice Evaluation and Safety
Section 1.3, Page 3
{7}------------------------------------------------
510(k) No.:
Device Name: CN2-8 for use with SONOACE R3 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(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | Note 1 | Notes 2,7,8 | ||
| Abdominal | N | N | N | N | Note 1 | Notes 2,7,8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Steel Bopper morades Fower (Ampinade) Doppler
Note B+M, B+PW, B+Color, B+PD, B+Color+PW, B+PD+PW, B+Color+Color M
510
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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mh. S. D.K.
(Division Sign-Off)
Indications For Use
Division of Radiological Devices Office of Ir fitro Diagnostic Device Evaluation and Safety
Section 1.3, Page 4
{8}------------------------------------------------
510(k) No.:
Device Name: CN4-9 for use with SONOACE R3
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(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | |||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | N | N | N | N | Note 1 | Notes 2,8 | |||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | N | N | N | N | 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.) | |||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | Note 1 | Notes 2,8 | ||
| Other (spec.) |
N= new indication; P= 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, 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)
(Division Sign-Off)
Indications For Use
Division of Radiological Devices Office of Ir Evaluation and Safety
510K K101829
{9}------------------------------------------------
SONOACE R3 Diagnostic Ultrasound System
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.:
.
Device Name: EC4-9 for use with SONOACE R3
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| General(Track I only) | Clinical ApplicationSpecific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& 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 | ||||||||
| 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. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral 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 Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+Color, B+PD, B+PD, B+PD+PW, B+Color+Color M
510
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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Indications For Use
Division of Radiological Devices Office of iagnostic Device Evaluation and Safety
Section 1.3, Page 6
{10}------------------------------------------------
510(k) No.:
Device Name: L5-12/60 for use with SONOACE R3
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(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal (See Note 3) | |||||||
| Abdominal | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | Note 1 | Note 2,5,6 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 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 | Note 2,5,6 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2,5,6 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | Note 1 | Note 5,6 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; 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+PD+PW, B+Color+Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
5101
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)
Indications For Use
h. D'H
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Division of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In
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510(k) No.:
Device Name: LN5-12/40 for use with SONOACE R3
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(Track I only) | Specific | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) | |
| Ophthalmic | (Tracks I & III)Ophthalmic | ||||||||
| Fetal (See Note 3) | |||||||||
| Abdominal | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | N | N | N | N | Note 1 | Note 2,5,6 | |||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 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 | Note 2,5,6 | |||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2,5,6 | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | Note 1 | Note 5,6 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; 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+PW, B+Color+Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
510
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients.
Note 6: Abdominal congress and registers I vocal
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)
Indications For Use
Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Section 1.3, Page 8
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
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.(b)
Classification. Class II.