(14 days)
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, Adult Cephalic, Transrectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Pediatric, Peripheral vessel.
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, PW/CW Spectral Doppler mode, Harmonic imaging, 3D 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.
This document is a 510(k) summary for the SONOACE R7 Diagnostic Ultrasound System, which is a premarket notification to the FDA for a medical device. This type of submission generally demonstrates substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics against human readers or pathology.
Therefore, the provided document does not contain information related to:
- A table of acceptance criteria and reported device performance for clinical endpoints.
- Sample sizes used for a test set or data provenance in the context of clinical performance evaluation.
- Number and qualifications of experts used to establish ground truth for a test set.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study, effect size regarding human reader improvement with AI, or standalone algorithm performance.
- Sample size for a training set or how ground truth for the training set was established.
Instead, the document focuses on regulatory aspects to demonstrate substantial equivalence to previously cleared devices.
Here's the relevant information that can be extracted from the provided text:
1. Acceptance Criteria and Device Performance:
The document describes the device's adherence to various safety and performance standards rather than clinical acceptance criteria based on disease detection or diagnostic accuracy. The device's "performance" in this context refers to its technical capabilities and compliance with established industry and regulatory standards.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| Device Safety | UL 60601-1, Safety requirements for Medical Equipment | Designed to meet the standard. |
| CSA C22.2 No. 601.1, Safety requirements for Medical Equipment | Designed to meet the standard. | |
| IEC60601-2-37, Diagnostic Ultrasound Safety Standards | Designed to meet the standard. | |
| EN/IEC60601-1, Safety requirements for Medical Equipment | Designed to meet the standard. | |
| EN/IEC60601-1-2, EMC requirements for Medical Equipment | Designed to meet the standard. | |
| ISO10993-1, Biocompatibility | Designed to meet the standard. | |
| Acoustic Output | NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | Real-time acoustic output display with mechanical index and thermal index automatically displayed. |
| NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment | Real-time acoustic output display with mechanical index and thermal index automatically displayed. | |
| IEC 61157, Declaration of the acoustic output | Designed to meet the standard. | |
| Functional Equivalence | Substantial Equivalence to Predicate Devices: SONOACE X8 (K093714) and MySono U5 (K100186) | The SONOACE R7 is substantially equivalent in technology (acquires ultrasound data, displays B mode, M mode, Color Doppler, Power Doppler, PW/CW Spectral Doppler, Harmonic imaging, 3D imaging, specialized measurements, and calculations) and intended uses to the predicate devices. |
2. Sample size used for the test set and the data provenance:
Not applicable. The document describes a substantial equivalence submission, which typically relies on comparisons to predicate devices and adherence to recognized standards, rather than new clinical studies with test sets of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no external clinical test set with ground truth was described in this 510(k) summary for device performance evaluation.
4. Adjudication method for the test set:
Not applicable, as no external clinical test set with ground truth was described.
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 applicable. This is a diagnostic ultrasound system, not an AI-assisted diagnostic device, and no MRMC study or AI performance evaluation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a diagnostic imaging system, not a standalone algorithm.
7. The type of ground truth used:
Not applicable in the context of clinical performance evaluation against disease. The "ground truth" here is the adherence to safety and performance standards and the functional equivalence to established predicate devices.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device that would typically involve a specific training set of data.
9. How the ground truth for the training set was established:
Not applicable.
{0}------------------------------------------------
14102065
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)
MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea
Contact Person:
Kyeong-Mi, Park Regulatory Affairs Manager
| Telephone: | 82.2.2194.1373 |
|---|---|
| Facsimile: | 82.2.556.9209 |
Data Prepared: July 2, 2010
2. Name of the device:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
| SONOACE R7 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:
K100186, MySono U5 Diagnostic Ultrasound System K093714, SONOACE X8 Diagnostic Ultrasound System
510(k) Summary / Statement Certification
ATTACHEMENT I
{1}------------------------------------------------
SONOACE R7 Diagnostic Ultrasound System
4102065
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, PW/CW Spectral Doppler mode, Harmonic imaging, 3D 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.
The SONOACE R7 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 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, Adult Cephalic, Transrectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Pediatric, Peripheral vessel.
6. Technological Characteristics:
The SONOACE R7 is substantially equivalent to the SONOACE X8 Diagnostic Ultrasound System, cleared via K093714, and the MySono US Diagnostic Ultrasound System, cleared via K100186. 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 logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street BUFFALO MN 55313
AUG 062010
Re: K102065
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, and ITX Dated: July 22, 2010 Received: July 23, 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 R7 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C2-8 |
|---|
| ER4-9/10ED |
| EV4-9/10ED |
| L3-8 |
| L5-12/50EP |
| HL5-12ED |
{3}------------------------------------------------
P2-4AH 3DC2-6 3D4-8ET
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.html 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 Jana Delfino at (301) 796-6503.
Sincerely vours.
Ariel Hf
Donald J. 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}------------------------------------------------
SONOACE R7 Diagnostic Ultrasound System
SECTION 1.3 INDICATIONS FOR USE
510(k) Number (if known): K102065
AUG 0 6 2010
SONOACE R7 Diagnostic Ultrasound System Device Name:
Indications for 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 Organ, Adult Cephalic, Trans-rectal, Transvaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Pediatric, Peripheral vessel.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
510K
signature
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Section 1.3, page 1
Indications for Use
{5}------------------------------------------------
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(Track 1 only) | Specific(Tracks I & II) | 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 | N | Note 1 | Notes 2, 4, 7, 8 | |
| Intra-operative ( See Note 6 ) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9 | ||
| Small Organ ( See Note 5 ) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Trans-rectal | N | N | N | N | Note 1 | Note 2, 8 | ||
| Trans-vaginal | N | N | N | N | Note 1 | Note 2, 8 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; I = previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppier includes Power (Amplitude) Doppler
Nate 1: B/M, B/PWD, B/Color Doppler, B/Color Doppler/PWD, B/Power Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infectility monitoring of follicle development
Note 4: Color M-mode
Note 5; For example: thyroid, breast, scrotum and penis in adult, pediativ and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (FIII)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
DAeB
(Division Sign-Off) Division of Radiological Devices Office of In ritro Diagnostic Devices
I / Diagnostic Device Evaluation and Safety
510K K10265
{6}------------------------------------------------
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(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(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& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; I = previously cleared by FDA K093714; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Nate 1: B/M, B/PWD, B/Color Doppler/PWD, B/Power Dopplex/PWD, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, serotum 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
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
signature
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K62065
{7}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No .:
Device Name: ER4-9/10ED for use with SONOACE R7
| 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 | ||||||||
| 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA K093714; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler/PWD, B/Power Doppler/PWD, B/Power Doppler/Color M
Note 2: Includes imaging for guidance of bropsy
Note 3: Includes infectility 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
Note 9: Panoramic 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
810K
{8}------------------------------------------------
510(k) No.:
Device Name: EV4-9/10ED for use with SONOACE R7
| Clinical Application | Mode of Operation (* includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & II) | 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 | |||||||||
| 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.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; ! = previously cleared by FDA K093714; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Color Doppler/PWD, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (TIII)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Section 1.3, page 5
Indications for Use
(Division Sign-Off Division of Radiological D Office of In Vitro Diagnostic Device Evalu and Safety
510K K102065
{9}------------------------------------------------
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(Track I only) | Specific(Tracks I & II) | 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 | Note 2, 5, 6, 7, 9 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | ||
| 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 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
, اس
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler, B/Color Doppler/PWD, B/Pawer Doppler/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrottin and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (TIII)
- Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OFVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
DHR
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102065
{10}------------------------------------------------
510(k) No .:
Device Name: L5-12/50EP for use with SONOACE R7
| 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 | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| 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 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | |
| Other (spec.) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA K093714; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler/PWD, B/Power Doppler/PWD, B/Color Doppler/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, breast, scrotum and penis in adult, pediativ and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
· Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) : Prescription Use (Per 21 CFR 801.109)
Indications for Use
DSA2
Section 1.3, page 7
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Disanostic De Evaluation and Safety
K102065
610K
{11}------------------------------------------------
510(k) No ::
Device Name: HL5-12ED 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(Track I only) | Specific(Tracks I & II) | 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 | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| 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 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; I'= previously cleared by FDA K093714; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler/PWD, B/Power Doppler/PWD, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
610
Indications for Use
Duy R
Section 1.3, page 8
(Division Sign-Off ion of Radiological Devices Office of In Evaluation and Safety
{12}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No .:
--
Device Name: P2-4AH for use with SONOACE R7 or fluid flow
| 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 1 only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined *(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K093714; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: BIM, BIPWD, BIColor Doppler, B/Color Doppler/PWD, B/Power Dopplet/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, breast, scrolum and penis in adult, pediatric and nevenatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (1111)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
se
Section 1.3, page 9
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evale ation and Safety
{13}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.:
Device Name: 3DC2-6 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(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler* | Combined*(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Abdominal | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; I'= previously cleared by FDA K093714; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler includes Power (Amplinde) Doppler
Note 1: BiM, LVPWD, B/Color Doppler, I//Color Doppler/PWD, B/Power Doppler/PWD, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and peris in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (Till)
Note 8: 3D maging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801 109)
Indications for Use
ﺴﻪ
Section 1.3, page 10
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102065
{14}------------------------------------------------
510(k) No.:
Device Name: 3D4-8ET for use with SONOACE R7
| 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) | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Abdominal | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Note 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.) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication: 17= previously cleared by FDA K093714; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
1 1 1 2 2 ppter in only 1 2 ( 2 minutes 2 ( 2 per 2 ( 2 ) 2 ) 2 ( 2 ) 2 ) 2 ( 2 ) 2 ) 2 ( 2 ) 2 ) 2 ( 2 ) 2 ) 2 ( 2 ) 2 ) 2 ( 2 ) 2 ) 2 ( 2 ) 2 ) 2 ( 2 ) 2 ) 2 ) 2 ( 2 ) 2 )
Note 2: Includes imaging for guidance of bropsy Note 3: Includes infertility monitoring of follicle development
Note 4: Color Manude
Note 8: For numerical
Note 5: Vor example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and newnatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (TIII)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Indications for Use
DSR
Section 1.3, page 11
(Division Sign-Off Division of Radiological Devices Office of In itro Diagnostic Device Evaluation and Safety
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.