(43 days)
No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML algorithms in medical imaging.
No.
The device is clearly stated as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging and fluid analysis," and its function is to "acquire ultrasound data and to display the data" for "making a diagnosis." There is no mention of treating or preventing any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body."
No
The device description explicitly states it is a "diagnostic ultrasound system" and describes its function as acquiring ultrasound data and displaying it in various modes. This indicates the presence of hardware components (transducers, imaging system) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This describes an imaging device used to visualize internal structures and analyze fluids within the body.
- Device Description: The description details how the system acquires and displays ultrasound data in various modes (B mode, M mode, Doppler, etc.) and provides measurement and analysis packages. These are all functions related to in vivo imaging and analysis.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro). IVD devices typically involve testing blood, urine, tissue samples, or other biological specimens in a laboratory setting.
Therefore, the SONOACE R7 Diagnostic Ultrasound System is an in vivo 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 Pediatricand Peripheral vessel.
Product codes
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(including Directional Power Doppler mode), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The SONOACE R7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organs (thyroid, parathyroid, breast, scrotum, penis), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel, Renal, Gynecology/Pelvis.
Indicated Patient Age Range
Adult, Pediatric, Neonatal (for specific applications only, e.g., Neonatal Cephalic, Small Organ).
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 applicable. The subject of this submission, SONOACE R7, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SONOACE R7 Diagnostic Ultrasound System(K112646), ACCUVIX A30 Diagnostic Ultrasound System(K112339)
Reference Device(s)
UGEO HM70A Diagnostic Ultrasound System (K130803), EKO 7 Diagnostic Ultrasound System (K101455), UGEO H60 Diagnostic Ultrasound System (K122583), UGEO PT60A Diagnostic Ultrasound System (K132228), MySono U6 Diagnostic Ultrasound System (K113381)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 2 7 2013
510(k) Premarket Notification
SONOACE R7 Diagnostic Ultrasound System
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1. Submitter's Information: 21 CFR 807.92(a)(1)
SAMSUNGMEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Contact Person: . Kyeong-Mi, Park
Regulatory Affairs Manager
| Telephone: | 82.2.2194.1373 |
|---|---|
| Facsimile: | 82.2.556.3974 |
Data Prepared:September 9, 2013
2. Name of the device:
Common/Usual Name: Diagnostic Ultrasound System and Accessories Proprietary Name: SONOACE R7 Diagnostic Ultrasound System Product Code FR Number Classification Names: Ultrasonic Pulsed Doppler Imaging System 892.1550 IYN IYO Ultrasound Pulsed Echo Imaging System 892.1560 ITX 892.1570 Diagnostic Ultrasound Transducer
3. Identification of the predicate or legally marketed device:
- SONOACE R7 Diagnostic Ultrasound System(K112646) -
- UGEO HM70A Diagnostic Ultrasound System (K130803) -
- ACCUVIX A30 Diagnostic Ultrasound System(K112339) -
- EKO 7 Diagnostic Ultrasound System (K101455) .
- UGEO H60 Diagnostic Ultrasound System (K122583) -
- UGEO PT60A Diagnostic Ultrasound System (K132228) -
- MySono U6 Diagnostic Ultrasound System (K113381) ﮯ
- The proprietary names of predicate devices (K130803 / K122583) have been changed to UGEO HM70A / ※ UGEO H60 Diagnostic Ultrasound System from UGEO H70c / UGEO G60 Diagnostic Ultrasound System on FDA Databases.
510(k) Summary
Page 1 of 6
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(including Directional Power Doppler mode), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The SONOACE R7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
5. Intended Uses:
The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial),Cardiac Adult, Cardiac Pediatricand Peripheral vessel.
6. Technological Characteristics:
The SONOACE R7is substantially equivalent with respect to safety, effectiveness, and functionality to the SONOACE R7 Diagnostic Ultrasound System (K112646) and ACCUVIX A30 Diagnostic Ultrasound System (K112339).
It is substantially equivalent with respect to safety, effectiveness, and functionality to the Bodymarker of SONOACE R7(K112646) in regards to the device with e-Motion Marker.
All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.
These are described in detail in the technological characteristics comparison table as below.
2
0NOACE R7 Diagnostic Ultrasound System
| Feature/Characteristics | The subject device
SONOACE R7 | SONOACE R7
(K112646) | ACCUVIX A30
(K112339) | EKO 7
(K101455) | UGEO HM70A
(K130803) | UGEO H60
(K122583) | MySono U6
(K113381) | UGEO PT60A
(K132228) |
|----------------------------------------------------|----------------------------------|-------------------------|--------------------------|--------------------|-------------------------|-----------------------|------------------------|-------------------------|
| Indication for Use | | | | | | | | |
| - Fetal | √ | √ | √ | √ | √ | √ | √ | √ |
| - Abdominal | √ | √ | √ | √ | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ | √ | √ | √ | √ |
| - Small Organ | √ | √ | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Conventional) | √ | √ | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Superficial) | √ | √ | √ | √ | √ | √ | √ | √ |
| - Cardiac Adult | √ | √ | √ | √ | √ | √ | √ | √ |
| - Cardiac Pediatric | √ | √ | √ | √ | √ | √ | √ | √ |
| - Peripheral vessel | √ | √ | √ | √ | √ | √ | √ | √ |
| Scanhead Types | | | | | | | | |
| - Linear Array | √ | √ | √ | √ | √ | √ | √ | √ |
| - Curved Linear Array | √ | √ | √ | √ | √ | √ | √ | √ |
| - Endocavity | √ | √ | √ | √ | √ | √ | √ | √ |
| - Phased Array | √ | √ | √ | √ | √ | √ | √ | √ |
| - Static Probes | √ | √ | √ | √ | √ | √ | √ | √ |
| Scanhead Frequency | | | | | | | | |
| - 1.0 - 20.0 MHz | √ | √ | √ | √ | √ | √ | √ | √ |
| Modes of Operation | | | | | | | | |
| - B-mode | √ | √ | √ | √ | √ | √ | √ | √ |
| - M-mode | √ | √ | √ | √ | √ | √ | √ | √ |
| - Pulsed wave (PW) Doppler | √ | √ | √ | √ | √ | √ | √ | √ |
| - Continuous wave (CW) Doppler | √ | √ | √ | √ | √ | √ | √ | √ |
| - Color Doppler | √ | √ | √ | √ | √ | √ | √ | √ |
| - Power Amplitude | √ | √ | √ | √ | √ | √ | √ | √ |
| Feature / Characteristics | The subject device
SONOACE R7 | SONOACE R7
(K112646) | ACCUVIX A30
(K112339) | EKO 7
(K101455) | UGEO HM70A
(K130803) | UGEO H60
(K122583) | MySono U6
(K113381) | UGEO PT60A
(K132228) |
| Doppler | √ | √ | √ | √ | √ | √ | √ | √ |
| Tissue Harmonic
Imaging | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D/4D imaging mode | √ | √ | √ | √ | √ | √ | √ | √ |
| Combined modes | √ | √ | √ | √ | √ | √ | √ | √ |
| Safety & EMC Compliance | | | | | | | | |
| IEC60601-1 | √ | √ | √ | √ | √ | √ | √ | √ |
| UL 60601-1 | | | | | | | | |
| CSA C22.2 No.601.1 | | | | | | | | |
| IEC 60601-2-37 | √ | √ | √ | √ | √ | √ | √ | √ |
| IEC 60601-1-2 | | | | | | | | |
| Acoustic Output Display Standard | √ | √ | √ | √ | √ | √ | √ | √ |
| Track 3 | | | | | | | | |
| Patient Contact Materials
tested to ISO 10993-1 | √ | √ | √ | √ | √ | √ | √ | √ |
| Functionality | | | | | | | | |
| Quick Scan (Q Scan) | √ | √ | √ | √ | √ | √ | √ | √ |
| Spatial Compound
Imaging | √ | √ | √ | √ | √ | √ | √ | √ |
| SMDR (Dynamic MR
Plus) | √ | √ | √ | √ | √ | √ | √ | √ |
| Auto IMT+(Auto IMT) | √ | √ | √ | √ | √ | √ | √ | √ |
| Strain | √ | √ | √ | √ | √ | √ | √ | √ |
| Stress Echo | √ | √ | √ | √ | √ | √ | √ | √ |
| Panoramic | √ | √ | √ | √ | √ | √ | √ | √ |
| Elastoscan | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D Imaging
(Volume Data
Acquisition) | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D Imaging presentation
(3D Cine/4D Cine) | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D Rendering | √ | √ | √ | √ | √ | √ | √ | √ |
| MPR(Multi Planer
Render) | √ | √ | √ | √ | √ | √ | √ | √ |
| 3D XI | √ | √ | √ | √ | √ | √ | √ | √ |
fechnological Characteristics Comparison Table>
510(k) Summary
.
.
:
.
Page 3 of 6
3
SONOACE R7 Diagnostic Ultrasound System
510(k) Summary
·
Page 4 of 6
4
.
KONOACE R7 Diagnostic Ultrasound System
| Feature / Characteristics | The subject
device | The predicate devices | | | | | | |
|---------------------------|-----------------------|-------------------------|--------------------------|--------------------|-------------------------|-----------------------|------------------------|-------------------------|
| | SONOACE R7 | SONOACE R7
(K112646) | ACCUVIX A30
(K112339) | EKO 7
(K101455) | UGEO HM70A
(K130803) | UGEO H60
(K122583) | MySono U6
(K113381) | UGEO PT60A
(K132228) |
| MSV(Multi Slice View) | | V | V | V | V | V | V | V |
| Oblique View | | V | V | V | V | V | V | V |
| - 3D MagiCut | | V | V | V | V | V | V | V |
| - e-Motion Marker | | | | | | | | |
- BodyMarker
510(k) Summary
5
7. A brief discussion of the bench and non-clinical tests conducted on the subject device
The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.
The SONOACE R7 and its application comply with voluntary standards as below:
- UL 60601-1. Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- IEC60601-2-37, Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1,Safety requirements for Medical Equipment
- EN/IEC60601-1-2,EMC requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1, Biocompatibility
- ISO14971, Application of risk management to medical devices
Summary of Clinical Tests:
Not applicable. The subject of this submission, SONOACE R7, did not require clinical studies to support substantial equivalence.
8. Conclusion
Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the SONOACE R7to be as safe, as effective, and performanceis substantially equivalent to thepredicate devices.
END of 510(K) Summary
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2013
SAMSUNG MEDISON CO., LTD C/O MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL REGULATORY TECHNOLOGY SERVICES LLC 1394 25TH STREET NW BUFFALO MN 55313
Re: K133505
Trade/Device Name: SONOACE R7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 13, 2013 Received: November 14, 2013
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the SONOACE R7 Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model Number | ||
|---|---|---|
| C2-5 | C2-8 | C4-9/10ED |
| ER4-9/10ED | EV4-9/10ED | L3-8 |
| L5-12/50EP | LN5-12 | HL5-12ED |
| P2-4AH | P3-7AC | 3DC2-6 |
| 3D4-8ET | 3D4-9ES | C4-9 |
| CF4-9 | ER4-9 | EVN4-9 |
| L5-12/50 | P2-4 | PN2-4 SP3-8 |
7
| . | 3D4-8 | 3D4-9 | VN4-8 |
|---|---|---|---|
| CW2.0 |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
FDA
For
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
SONOACE R7 Diagnostic Ultrasound System
Indications for Use (Describe)
The SONOACE R7 Diagnostic Ultrasound System and transcheers are intended for disgnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Trans-recal, Transvaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Pediatic and Peripheral vessel.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last pege.
9
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 I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | ||
| Abdominal(See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12 | ||
| Neonatal Cephalic | P | P | P | P | Note 1 | Notes 2,8, 9 | ||
| Adult Cephalic | P | P | P | P | P | Note I | Note 4, 7 | |
| Trans-rectal | P | P | P | P | Note 1 | Note 2, 7, 8, 11 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8, 11 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note I | Note 2, 5, 6, 7, 9, 12 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 12 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | Note I | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note I | Note 4. 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 12 |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power ( Amplitude) Doppler
Color Doppler includes Power (Amplinude) Dopler
Note I : B-M, B+PW, B+C, B+PD, B+CW, B+CW, B+C+PW, B+C+PW, B+DPD+PW, B+C+M, B+C+CW, B+PD+CW, B+PD-CW, Dual(B. B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example; thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9; Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note I I : ElastoScan
Notel 2; Spatial Compound Imaging .
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
10
. 510(k) Premarket Notification :
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.:
Device Name: C2-5 for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (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 1 | Notes 2, 7, 8, 9 | |||
| Abdominal(See Note 10) | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | |||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | |||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared byFDA K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology Petvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801 109)
Indications for Use
11
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
.
510(k) No.:
Device Name: C2-8 for use with SONOACE R7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 1 | Notes 2, 7, 8, 9 | ||
| Abdominal(See Note 10) | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared byFDA K112646; E= added under Appendix E
Additional Comments:
・
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5; For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vesse!
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
12
510(k) No.:
Device Name: C4-9/10ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 | P | Note 1 | Notes 2,8, 9 | |
| Abdominal(See Note 10) | P | P | P | P | P | Note 1 | Notes 2,8, 9 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,8, 9 | |
| Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Notes 2,8, 9 | |
| Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 2,8, 9 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,8, 9 |
| Other (spec.) |
N= new indication; P= previously cleared byFDA K112646; E= added under Appendix E
. Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Collar Dopper Interest one ( milipinate) Dopper
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+C+PW, B+PD+PW, B+C+M, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color Momode
Note 5: For example: thyroid, parathyroid, breast, serotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
.
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
13
510(k) No .:
Device Name: ER4-9/10ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 1 | Notes 2, 8 | ||
| Abdominal(See Note 10) | P | P | P | P | Note 1 | Notes 2, 8 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | Note 1 | Notes 2, 8 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Notes 2, 8 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Nate I: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+TD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
. -
14
510(k) No .:
.
Device Name: EV4-9/10ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (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 1 | Notes 2, 8 | ||
| Abdominal ( See Note 10 ) | P | P | P | P | Note 1 | Notes 2, 8 | ||
| Intra-operative ( See Note 6 ) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared by FDAK112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Dopper Mellaus Front (Timpinson Boppia
Note 1: B+M, B+C+PD, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
15
510(k) No.:
Device Name: L3-8 for use with SONOACE R7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal ( See Note 3 ) | |||||||||
| Abdominal ( See Note 10 ) | |||||||||
| Intra-operative ( See Note 6 ) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | N | N | N | N | Note I | Note 2, 5, 6, 7, 9, 12 | |||
| Small Organ ( See Note 5 ) | N | N | N | N | Note I | Note 2, 5, 6, 7, 9, 12 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9, 12 | |||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2. 5, 6. 7, 9, 12 | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note I | Note 2, 5, 6, 7, 9, 12 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801 109)
Indications for Use
16
510(k) No .:
Device Name: L5-12/50EP for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal(See Note 10) | ||||||||
| 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, 12 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 12 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 12 | ||
| Musculo-skel. (Superfic.) | P | P | P | - | P | Note 1 | Note 2, 5, 6, 7, 9, 12 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 12 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K 12646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note II: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
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 I only) | Specific | |||||||||
| (Tracks 1 & III) | B | M | PWD | CWD | Color | |||||
| Doppler* | Combined* | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal (See Note 3) | ||||||||||
| Abdominal(See Note 10) | ||||||||||
| Intra-operative (See Note 6) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Laparoscopic | |||||||||
| Pediatric | P | P | P | P | Note I | Notes 2,5.6, 9, 11, 12 | ||||
| Small Organ (See Note 5) | P | P | P | P | Note I | Notes 2,5,6, 9, 12 | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note I | Notes 2,5,6, 9, 12 | ||||
| Musculo-skel. (Superfic.) | P | P | P | P | Note I | Notes 2,5,6, 9, 12 | ||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | Note I | Notes 5,6, 9, 12 | |||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E
Additional Comments:
Color Doppier includes Power (Amplitude) Doppler
Color Dopper Mitiades Port (mipinale) Boppia
Nota 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6; Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
18
510(k) No.:
Device Name: HLS-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 & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal ( See Note 3 ) | |||||||
| Abdominal ( See Note 10 ) | ||||||||
| Intra-operative ( See Note 6 ) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 12 | ||
| Small Organ ( See Note 5 ) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 12 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 12 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 12 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | 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, 12 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Nota I: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2; Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
19
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 (See Note 10) | 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K 112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Coll Dopper Minister only (rispinser) Dopping Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
20
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
510(k) No .:
Device Name: P3-7AC 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 | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal(See Note 10) | 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared by FDA K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Dopper alchades rone («mphade) Boppiel
Note 1: B+M, B+PW, B+C, B+PD, B+DD, B+C+PW, B+C+PW, B+C+PW, B+C+PW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example; thyroid, parathyoid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
.
21
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 | Color | ||||||
| Doppler . | Combined* | ||||||||||
| (Spec.) | Other | ||||||||||
| (Spec.) | |||||||||||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal (Sec Note 3) | P | P | P | P | Note l | Note 2, 7, 8, 9 | |||||
| Abdominal(See Note 10) | P | P | P | P | Note I | Note 2, 7, 8, 9 | |||||
| Intra-operative (See Note 6) | |||||||||||
| Intra-operative (Neuro.) | |||||||||||
| Fetal Imaging | Laparoscopic | ||||||||||
| & | |||||||||||
| Other | Pediatric | P | b | P | P | Note I | Note 2, 7, 8, 9 | ||||
| Small Organ (See Note 5) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans esoph (non-Cardiac) | |||||||||||
| Musculo-skel. (Convent.) | |||||||||||
| Musculo-skel. (Superfic.) | |||||||||||
| Intra-luminal | |||||||||||
| Other (spec.) | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac | Cardiac Pediatric | ||||||||||
| Trans-esophageal (Cardiac) | |||||||||||
| Other (spec.) | |||||||||||
| Peripheral | Peripheral vessel | ||||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA KI12646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Nate I: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
22
510(k) No .:
Device Name: 3D4-8ET 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) | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
. N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Dopper Motions Port (1.miphiles) Dopper D, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note II: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
23
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
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 I & III) | 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 (See Note 10) | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| 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 | Note 2, 7, 8 | ||
| 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 K112646; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppier netdas Forect (Antipliade) Dopper
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2; Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thytoid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
24
510(k) No .:
Device Name: C4-9for use with SONOACE R7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as tollows:
| Clinical Application | Mode of Operation (* includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & II) | B | M | PWD | CWD | Color | |||
| Doppler * | Combined * | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal (See Note 3) | P | P | P | P | Note 1 | Notes 8, 9 | |
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 8, 9 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Notes 8, 9 | ||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Notes 8, 9 | ||
| Neonatal Cephalic | P | P | P | P | Note 1 | Notes 8, 9 | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Supertic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Notes 8, 9 | |
| Other (spec.) |
No new mdreation: P : previously cleared byFDA K113381, E= added under Appendry E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Cool respectionals Pare (respirition) (1892) BeCW, B-C-PW, B-PD-PW, R-ITD+PW, B-C-M, B+C+M, B+C+CW, B+PD> Concurrence of CDRH, Oftice of In Vitro Diagnostics and Radiological Health (GIR) Preseription Use (Per 21 CFR 801,109)
27
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
510(k) No.:
Device Name: EVN4-9 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 | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal (See Note 3) | P | P | P | P | Note 1 | Notes 2, 7, 8 | |
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
| 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, 7, 8 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Supertic.) | ||||||||
| 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 K122583: E=added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B=M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+DY>PW, B+DYD+PW, B+C+M, B+C+CW, B+PD-CW, Dual(B, B+C. B+PD, B+TD, B+PD, B+PD)
Note 2: Includes imaging for guidance of bropsy
Note 3; Includes infertility monitoring of folliele development
Note 4: Color M-mode
Note 5: For example: thyroid, preast, scrotum and penis in adult, pediatric and nearmall patients
Note 6: Abdominal organs and peripheral vessel
Note 7; Tissue Harmonic Imaging (1711)
Note 8: 3D imaging
Note 9: Panoranic imaging
Note 10: Includes Remal, Gyuecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (CJR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
28
510(k) No.:
Device Name: L5-12/50 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 & II) | B | M | PWD | CWD | Color | |||
| Doppler * | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal(See Note 10) | ||||||||
| 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, 12 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9, 12 | ||
| Musculo-skel (Supertic.) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9, 12 | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9, 12 | |
| Other (spec.) |
N=new indication: P=previously cleared by FDA: E= added under Appendix E
Additional Comments:
Color Doppier includes Power (Ampliude) Doppler
Cool ropper metable from (calphiae) rapper
Note 1: R+M, R+PW, R+C, R+PD, B+CW, B+C+PW, B+C+PW, B+111+PW, R+TD+PW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+C+CW, B+C+CW, B+0D+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for guidance of broysy
Note 3: Includes infertifity monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, serotom and penis in addle, pediatic and neonalal patients
Note 6; Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8; 3D imaging
Note 9: Panoranne imaging
Note 10; Includes Renal, Gynecology/Pelvis
Note II: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Fitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801, 109)
Indications for Use
29
510(k) No.:
Device Name: P2-4 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/See Note 10 | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| 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 | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 |
| Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K113381; E= added under Appendis E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Nae I: B+M, R+PW, B+C, B+PD, B+DM), B+CW, B+CW, B+C+PW, B+DPD+PW, B+TD>PW, B+C+M, B+C+CW, B+PD+CW, Daa(B, B+C, B=PD, B+TD, B+PD)
Note 2: Includes inaging for guidance of biopsy
Note 3: Includes infectility monitoring at tollicle development
Note 4: Color M-mode
Note 5: For example: thywid, preast, scrotum and penis in adult, pediatin and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harnonic Imaging (THD)
Note S: 3D imaging
Note 9: Panoramic imaging
Note 10; Includes Renal. Gynecology:Pelvis Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Preseription Use (Per 21 CFR 801,109)
Indications for Use
30
510(k) No.:
Device Name: PN2-4 for use with SONOACE R7 Imended 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 (See Note 10) | P | P | P | P | P | Note 1 | Note 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 7 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | ||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
: N= new indication; P= previously cleared byFDA K 132228; E= added under Appendix E
Additional Comments:
:
.
Color Doppler includes Power (Amplitude) Dopplet
Note i Ball BePW Hoc, 8-19, B-DPD, B+CW, B+C+PW, B+DPDPW, B-TDPW, B+C+M, B+C-CW, B+PD-CW, Dual(B, B:C, B:PD, B+TD, B+PD)
None 2: Includes imaging for guidance of biopsy
Note 3: Includes infertifity monitoring of tollicle development
Note 4: Color M-mode
Note 5: For example: thytoid, garathyroid, breast, sciolum and periis in adult, pediative and nequatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonie Imaging (THI)
Note 8: 3D imaging
Note 9: Panoranic imaging
Note 10 Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan Note 12: Spatial Compound Imaging
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
31
510(k) No.:
Device Name: SP3-8 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 | Color | ||||
| Doppler * | Combined * | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal (See Note 3) | ||||||||
| Abdominal(See Note 10) | N | N | N | N | N | Note 1 | Note 4, 7 | ||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel (Supertic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 | ||
| 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
Nate 1: Boat, Bopw, Bed, Repo, Retw, BeCw, BeCw, BeCarw, B-PD-PW, B+DYD-PW, B+C+M, B+C+CW, B-PD+CW, Dual(B, B+C. I3+PD, B+TD, B+PD) 1
Note 2: Includes imaging for guidance of bropsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
・
Note 5; For example: thyroid, preast, scrotum and genis in adult, pediatic and neonatal patients
Note b: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panorame imaging
Note 16: Includes Renal, Gynecology/Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (GR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
32
510(k) No .:
Device Name: 3D4-8 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 1 & 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 1 | Note 2, 7, 8, 9 | |
| Abdominal(See Note 10) | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent) | ||||||||
| Musculo-skel (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared by FDA K 12646; E=added under Appendix E
Additional Comments:
Color Doppier includes Power (Amplitude) Doppler
Cold Dapper action of the (Angliade) Dognet
Nate 1: ReMA Replier (Angliade) Bell), BeCW, B-C-PW, B-ID-PW, B-IDPD-PW, B+C-M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)
Note 2: Includes imaging for goidance of bropsy
Note 3; Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example; ahyroid, breast, scrotum and penis in addly, pediative and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 31) imaging
Note 9: Panoramic imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note II : ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OR) Prescription Use tPer 21 CFR 801.109)
Indications for Use
33
510(k) No.:
Device Name: 3D4-9 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 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(See Note 10) | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Fetal Imaging | ||||||||
| & Other | 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, 8 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Supertic.) | ||||||||
| 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 K122583: E= added under Appendix 13
Additional Comments:
(_olor Doppler includes Power (Amplitude) Doppler
Cool request and Port (ruiphisos) roopics
Note 1: 14-M, B=PW, B+C, R+PD, B+CW, B+C+PW, B+C+PW, B+P1)+PW, B+C+N+ B+C+N+ B+C+CW, B+YD+CW, DualqB, B+C, R+PD, B+TD, B+PD)
Note 2, Includes imaging for guidance of bropsy
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 parients
Note 6: Abdominal organs and peripheral vessel
Note 7. Tissue Harmonie Imaging (THI)
Note 8: 31) imaging
Note 9; Panorame imaging
Note 10: Includes Rena), GynecologyPelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (ORS Prescription Use (Per 21 CFR 801,109)
Indications for Use
34
510(k) No.:
Device Name: VN4-8 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 | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | N | N | N | N | Note 1 | Note 2, 7, 8, 9 | ||
| Abdominal(See Note 10) | N | N | N | N | Note 1 | Note 2, 7, 8, 9 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | Note 2, 7, 8, 9 | ||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent) | ||||||||
| Musculo-skel (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared by FDA K130803: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Nate 1: BoM, B-PW, B-C, FFPD, B-DPD, B+CW, B+C+PW, B-PD-PW, B+DPD+PW, B+C+M, B+C+CW, B+C+CW, B+YD+CW, Dual(B, B+C. B=PD, B=TD. B+PD)
Note 2: Includes imaging for guidance of bropsy
Note 3: Includes inferrility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example; thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonie Imaging (THI)
Note 8: 3D imaging
Note 9: Paneramic imaging
Note 10: Includes Renal, Gynecology:Pelvis
Note 11: ElastoScan
Note 12: Spatial Compound Imaging
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)
Indications for Use
35
510(k) No.:
Device Name: CW2.0 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 (See Note 10) | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro ) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | P | |||||||
| Cardiac | Cardiac Pediatric | P | ||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | ||||||
| Other (spec.) |
N= new indication: P= previously cleared by FDA K 130803: E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppter
Cood Depper licidues Pakel (ruipintue) Propped
Naie 1: B+M, R+PW, B+C, B+PD, B+D1, B+CW, B+CW, B+C+PW, B+CW, B+CPD+PW, B+C+M, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+7D, B+PD)
Note 2: Includes imaging for guidance of bropsy
Note 3; Includes intentifity monitoring of follicle development
Note 4: Calor M-mode
Note 5: For example; thereoid, breast, scrotum and penis in addla pediatic and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 10: Includes Renal. Gynecology/Petvis
Nole 11: ElastoScan
Note 12: Spatial Compound Imaging
Image /page/35/Figure/20 description: The image shows text that states "Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)". The text also states "Prescription Use (Per 21 CFR 801,109)". The text is centered on the page.