(30 days)
Not Found
No
The document describes standard ultrasound imaging modes and analysis packages, with no mention of AI, ML, or related terms.
No
The device is explicitly described as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging and fluid analysis of the human body," and its function is to "acquire ultrasound data and to display the data" to aid in diagnosis, rather than direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic ultrasound imaging and fluid analysis of the human body." Additionally, the "Device Description" mentions that it "offers analysis packages that provide information that is used to make a diagnosis."
No
The device is described as a "Diagnostic Ultrasound System" which inherently includes hardware components (transducers, system console) to acquire ultrasound data, not just software for processing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The SONOACE R7 is a diagnostic ultrasound system. It uses ultrasound waves to create images of structures inside the human body. This is an in vivo (within the living body) diagnostic method.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This refers to imaging the body directly, not analyzing samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, based on the provided information, the SONOACE R7 is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound innaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial). Cardiac Pediacric, Peripheral vessel.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (for example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Cardiac Adult, Cardiac Pediatric, Peripheral vessel. Additional functions include: Imaging for guidance of biopsy, infertility monitoring of follicle development, Tissue Harmonic Imaging (THI), 3D imaging, Panoramic imaging.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
Indicated Patient Age Range
Adult, Pediatric, Neonatal (for small organ applications).
Intended User / Care Setting
Competent health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Special 510(k)
OCT 1 2 2011
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR. Part 807, Subpart E. Section 807.92.
1. Submitter's Information: 21 CFR 807,92(a)(1)
SAMSUNG MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea
Contact Person:
Kyeong-Mi, Park Regulatory Affairs Manager
| Telephone: | 82.2.2194.1381 |
|---|---|
| Facsimile: | 82.2.556.9209 |
Data Prepared: July 11, 2011
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:
K 102065, SONOACE R7 Diagnostic Ultrasound System K093714, SONOACE X8 Diagnostic Ultrasound System
1
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, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
6. Technological Characteristics:
The SONOACE R7 is substantially equivalent to the SONOACE R7 Diagnostic Ultrasound System, cleared via K102065, and the SONOACE X8 Diagnostic Ultrasound System, cleared via K093714. All systems transmit ultrasonic energy into patients, then perform post processing of received choes 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 a logo with a circular border containing text, surrounding a stylized bird-like symbol. The text within the circular border appears to be in all caps, but is difficult to read due to the image quality. The bird-like symbol is composed of three curved lines, resembling the silhouette of a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Samsung Medison Co., Lid. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LL.C. 1394 25th Street NW BUFFALO MN 55313
OCT 1 2 2011
Re: K112646
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: TYN, IYO, and ITX Dated: September 9, 2011 Received: September 12, 2011
Dear Mr. Job:
We have reviewed vour 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
| ( C
2-5 | FILD
2 C
ﻤﺎ ﻳﻮﻧﻴﻮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ | -4-9/10ET |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 10EL
, 4-1
ﺗﺘ
ﻠ | P2-4AH | 1-ND-
| / |
|---|
| 0131 |
| 14-11 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| ેતા |
| ን - አ |
| ------------ |
| 2/50EP |
| t |
| -1 - |
| i |
| l |
| --------- |
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 vour 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/ReportalProblem/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 Jay Vaishnav at (301) 796-9580.
Sincerely Yours.
Michael O'Hearn for
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
4
SECTION 1.3 INDICATIONS FOR USE
510(k) Number (if known): _Kl12646
Device Name: SONOACE R7 Diagnostic Ultrasound System
Indications for Use:
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound innaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial). Cardiac Pediacric, 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 Devic Office of In Vitro Diagnostic Device Evaluation
510K K112646
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:
| Climical Application | Mode of Operation ( *includes simultancous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | ి. | M | PWD | CIVD | Color | Combined * | Other | |
| (Track I only) | (Tracks 1 & III) | Doppler* | (Spec.) | (Spec.) | |||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | រ្យ | P | > | P | Note I | Notes 2, 7, 8 | |||
| Abdominal | い | P | p | l> | p | Note I | Notes 2, 4, 7, 8 | ||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| ಳ | |||||||||
| Other | Pediatric | । > | P | P | ြာ | Note I | Note 2. 5. 6. 7. 8. 9 | ||
| Small Organ (See Note 5) | P | 1 > | > | {} | Note 1 | Note 2, 5, 6, 7, 9 | |||
| Neonatal Cephalic | א | 71 | 7 | ਮ | Note | Notes 2. 8 | |||
| Adult Cephalic | P | P | י | P | ן י | Note I | Note 4, 7 | ||
| Trans-rectal | p | ប្រ | 11 | יי | Note l | Note 2. S | |||
| Trans-vaginal | p | ﻟﺴﺎ | ( ) | P | Note 1 | Note 2. 8 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiae) | |||||||||
| Musculo-skel. (Convent.) | יי | ್ಕೆ ) | ( ) | P | Note I | Note 2, 5, 6, 7, 9 | |||
| Musculo-skel. (Supertic.) | P | ని | ું » | p | Note I | Note 2. 5. 6. 7. 9 | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | P | ប្រ | ్రా | ర్ | P | Note I | Note 4, 7 | ||
| Cardiac | Cardiae Pediatric | 】 | ្រ | 12 | ్రా | P | Note I | Note 4, 7 | |
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | ប្រ | ్ | ీ | P | Note I | Note 2, 5. 6, 7, 9 | ||
| Vessel | Other (spec.) |
N= new indication: P= previously cleared by FDA K102065; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: BIM, 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, 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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devic
510K K112646
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 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | 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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: BAM, B/PWD, B/Color Dopplex, B/Color Dopplex/PWD, B/Power Dopplex/PWD, (8/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsv
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, pediatrie and neonatal patients
5104
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 3: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Division Sign-Off
Division of Radiological Devices Office of In Vitro Diagnos aluation and Safety
7
510(k) No .:
Device Name: ER4-9/10ED for use with SONOACE R7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | 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-luminat | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously eleared by FDA K102065; E= added under Appendix E
.510K
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M. B/PWD, B/Color Dopplex, B/Color Dopple:/PWD, B/Power Dopplex/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, 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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
8
Special 510ck)
DIACNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.:
Device Name: EV4-9/10ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or thuid flow analysis of the human body as follows:
| | Mode of Operation (includes simultaneous B-mode)
Clinical Application | | | | | | | |
|--------------------------|---------------------------------------------------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| General | Specific | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other
(Spec.) |
| (Track I only) | (Tracks 1 & 111) | | | | | | | |
| 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 I | Notes 2, 8 |
| | Trans-vaginal | P | P | P | | P | Note I | Notes 2, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Supertic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/L/WD, B/Color Doppler, B/Calor Dapplex/PWD, B/Power Dopplex/Color Dopplex/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, seroum and penis in adult, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7; Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OLVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112646
9
510(k) No.:
Device Name: L3-S 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 | Color | |||
| Doppler* | 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 ! | Note 2, 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note I | Note 2, 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA KH02065; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: BAM, B/PWD, B/Color Dopplex/B/Color Dopplex/PWD, B/Power Dopplex/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 (THI)
Note 3: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Indications for Use
510K K112646
10
510(k) No .:
Device Name: L5-12/50EP for use with SONOACE R7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & II) | B | M | PWD | CWD | Color | ||||
| Doppler* | 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 | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Dopplex/PWD, B/Power Dopplex/PWD, B/Color Dopplex/Color M
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neconatal 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 301.109)
Avinash Patel
(Division Sign-Off)
Division of Radiological Det Office of In Vitro Diagno and Safety
Indications for Use
510K K1126416
11
510(k) No.:
Device Name: HL.5-12ED 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 1 & III) | B | M | PWD | CWD | Color | |||
| Doppler* | 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 I | Note 2, 5, 6, 7, 9 | ||
| Small Organ (See Note 3) | P | P | P | P | Note I | 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 I | Note 2, 5, 6, 7, 9 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note I | Note 2, 5, 6, 7, 9 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note I | Note 2, 5, 6, 7, 9 | |
| Other (spec.) |
N= new indication: P= previously cleared by FDA K102065; 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 Dopplex/PWD, B/Color Dopplex/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, scrown and penis in adult, pediatio and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Hannonic 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)
Richard D. Tilman
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K1126416
12
510(k) No .:
Device Name: P2-4AH 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 | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | P | P | P | P | P | Note I | 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 I | Note 4, 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Supertic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | Note I | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note I | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/N, B/PWD, B/Color Doppler. B/Color Dopplex/PWD, B/Power Dopplex/PWD, B/Color Doppler/Color M
Note 2: Includes imaging for guidance of biopsv
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, serotum and penis in adult, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 3: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiolonical Devices Office of In Vitro Diacnostic D Evaluation and Safety
Indications for Use .
510H
13
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 & II) | B | M | PWD | CWD | Color | ||||
| Doppler* | 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, 3 | |||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Supertic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K102065; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Dopplex, B/Color Dopplex/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, pediatic and neonatal patients
SIOK
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 3: 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801,109)
Alisa Roth
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
14
510(k) No.: Device Name: 3D4-8ET for use with SONOACE R7
Intended Use: Diagnostic ultrasound imaging or thuid 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 | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | P | P | P | P | Note I | Note 2, 7, 8 | ||
| Abdominal | P | P | P | P | Note I | Note 2, 7, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note I | 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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: ?= previously cleared by FDA K102065; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note I : 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 intertility monitoring of follicle development
Note 4: Color M-mode
Note >: For example: thyroid, breast, scrown and penis in adult, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D minging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Salety
Indications for Use .
510K K112646
15
510(k) No :
Device Name: C2-5 for use with SONOACE R7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & II!) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | 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.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | 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
Note 1: BiM. B/PWD, B/Color Doppler, B/Color Dopplex/PWD, B/Power Dopplex/PWD, B/Color Dopplex/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, scrown and penis in adult, pediatric and neonatal patients
510K
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) |
Mark D. Ott
(Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Indications for Use
16
510(k) No .:
Device Name: C4-9/10ED for use with SONOACE R7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal (See Note 3) | P | P | P | P | Note I | Notes 2, 8 | |
| Abdominal | P | P | P | P | Note I | Notes 2, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note I | Notes 2, S | ||
| Small Organ (See Note 3) | P | P | P | P | Note I | Notes 2. S | ||
| Neonatal Cephalic | P | P | P | P | Note I | Notes 2. 3 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note I | Notes 2, 8 | |
| 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: B/M, B/PWD. B/Color Dopplex, B/Color Dopplex/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, pediarie and neonatal patients
510K
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Hannonic Imaging (THI)
Note 8. 3D imaging
Note 9: Panoramic imaging
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Preseription Use (Per 21 CFR 801 109)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
17
510(k) No.:
Device Name: LN5-12 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 1 only) | Specific | |||||||
| (Tracks 1 & III) | B | M | PWD | CWD | Color | |||
| Doppler* | 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 | 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-esoph. (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 Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Notes 5,6 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K103722; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Dopplex PWD, B/Power DapplexPWD, BrColor DopplexColor 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, serotum and penis in adult, pediativ and neveaux patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note S: JD imaging
Note 9: Panoramic imaging
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|
| Prescription Use (Per 21 CFR 801.109) |
Michael D. O'Brien
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112646
Section 1.3, page 14
18
510(k) No.: Device Name: P3-7AC for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use: Diagnostic ultrasound imaging or hund flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks 1 & III) | B | M | PWD | CWD | Color | |||
| Doppler * | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 5) | ||||||||
| Abdominal | P | P | P | P | P | Note I | 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 I | Note 4, 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Supertic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | Note I | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note I | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | 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: B/M, B/PWD, B/Color Dopplex, B/Color Dapplex/PWD, B/Power Doppler/PWD, B/Color Doppler/Color M
Note 2: Includes innaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, serotum and penis in adult, pediatie and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonie Imaging (THI)
Note $. 3D imaging
Note 9: Panoramic imaging
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|
| Prescription Use (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
19
510(k) No .:
Device Name: 3D4-9ES 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 1 & III) | B | M | PWD | CWD | Color Doppler* | 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 | Note 2, 7, 3 | |||
| Trans-vaginal | P | P | P | P | Note 1 | Note 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 | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication: P= previously cleared by FDA K093714; E= added under Appendix E
510K
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B/M, B/PWD, B/Color Doppler/PWD, B/Power Dopplex/PWD, B/Color Dopplex/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 Harmonic Imaging (TI-II)
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) |
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Indications for Use