(15 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound imaging modes and analysis packages.
No
The device is explicitly described as a "diagnostic ultrasound system" intended for "diagnostic ultrasound imaging and fluid analysis," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." The "Device Description" also describes it as a "diagnostic ultrasound system".
No
The device description explicitly states it is a "diagnostic ultrasound system," which is a hardware device that uses software for control and processing. It also mentions transducers, which are hardware components.
Based on the provided information, the RS80A Diagnostic Ultrasound System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This involves imaging structures within the body, not analyzing samples taken from the body.
- Device Description: The description focuses on acquiring and displaying ultrasound data to visualize internal structures and fluid flow. It mentions analysis packages that provide information for diagnosis, but this information is derived from the ultrasound images, not from in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body. IVD devices are specifically designed for such purposes.
Therefore, the RS80A is a diagnostic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Product codes
IYN, IYO, ITX
Device Description
The RS80A 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, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode.Harmonic imaging. Tissue Doppler imaging. Tissue Doppler Wave. 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A 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 RS80A 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel, thyroid, breast, scrotum, penis, renal, pelvis
Indicated Patient Age Range
Adult, pediatric, neonatal
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. RS80A, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K133329, K130803, K112339, K103397, K123564, K050846
Reference Device(s)
Not Found
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
K141620
page 1 of 5
RS80ADiagnostic 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: March 24, 2013
- Name of the device:
Common/Usual Name:
. Diagnostic Ultrasound System and Accessories
Proprietary Name:
RS80A 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:
UGEO WS80A Diagnostic Ultrasound System (K133329) 1
UGEO HM70A Diagnostic Ultrasound System (K130803)
ACCUVIX A30 Diagnostic Ultrasound Svstem(K112339) -
ACCUVIX XG Diagnostic Ultrasound System (K 103397) -
LOGIQ E9Diagnostic Ultrasound System (K123564) -
-B-CAD (K050846)
The proprietary name of predicate device (K130803)was changedto UGEO HM70A Diagnostic ※ Ultrasound System from UGEO H70c Diagnostic Ultrasound System on FDADatabases.
510(k) Summary / Statement Certification
ATTACHEMENT I
1
4. Device Description:
The RS80A 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, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode.Harmonic imaging. Tissue Doppler imaging. Tissue Doppler Wave. 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A 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 RS80A 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 RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
6. Technological Characteristics:
The RS80Ais substantially equivalent with respect to safety, effectiveness, and functionality to the UGEO WS80A Diagnostic Ultrasound System (K133329), UGEO HM70A Diagnostic Ultrasound System (K130803), ACCUVIX A30 Diagnostic Ultrasound System (K112339)and ACCUVIX XG Diagnostic Ultrasound System (K103397).
It is substantially equivalent with respect to safety, effectiveness, and functionality to the Volume Navigation™(Needle Tracking) of GE's LOGIQ E9 (K123564) in regards to the device with Clear Track. It is substantially equivalent with respect to safety, effectiveness, and functionality to theMadipattern's B-CAD30System (K050846) in regards to the device with S-Detect.
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.
510(k) Summary / Statement Certification
ATTACHEMENT 1
2
RS80ADiagnostic Ultrasound System
| Feature /
Characteristics | The subject
device
RS80A | The predicate devices
UGEO
WS80A
(K133329) | ACCUVIX
A30
(K112339) | UGEO
HM70A
(K130803) | ACCUVIX
XG
(K103397) | LOGIQ E9
(K123564) | B-CAD
(K050846) |
|--------------------------------------|--------------------------------|-----------------------------------------------------|-----------------------------|----------------------------|----------------------------|-----------------------|--------------------|
| Indication for Use | | | | | | | |
| - Fetal/Obstetrics | √ | √ | √ | √ | √ | √ | - |
| - Abdominal | √ | √ | √ | √ | √ | √ | - |
| - Gynecology | √ | √ | √ | √ | √ | √ | - |
| - Pediatric | √ | √ | √ | √ | √ | √ | - |
| - Small Organ | √ | √ | √ | √ | √ | √ | - |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ | - |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ | - |
| - Trans-rectal | √ | √ | √ | √ | √ | √ | - |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ | - |
| - Musculo-skeletal
(Conventional) | √ | √ | √ | √ | √ | √ | - |
| - Musculo-skeletal
(Superficial) | √ | √ | √ | √ | √ | √ | - |
| - Urology | √ | √ | √ | √ | √ | √ | - |
| - 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
Doppler | √ | √ | √ | √ | √ | √ | - |
| - Tissue Harmonic
Imaging | √ | √ | √ | √ | √ | √ | - |
| - 3D/4D imaging mode | √ | √ | √ | √ | √ | √ | - |
| - Combined modes | √ | √ | √ | √ | √ | √ | - |
| Safety & EMC
Compliance | | | | | | | |
| - IEC 60601-1 | √ | √ | √ | √ | √ | √ | - |
| - UL 60601-1 | | | | | | | |
510(k) Summary / Statement Certification
ATTACHEMENT I
3
RS80ADiagnostic Ultrasound System
| Feature /
Characteristics | The subject
device
RS80A | The predicate devices | | | | | |
|-----------------------------------------------|--------------------------------|----------------------------|-----------------------------|----------------------------|----------------------------|-----------------------|--------------------|
| | | UGEO
WS80A
(K133329) | ACCUVIX
A30
(K112339) | UGEO
HM70A
(K130803) | ACCUVIX
XG
(K103397) | LOGIQ E9
(K123564) | B-CAD
(K050846) |
| - 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 (SMDR evo) | (1) | √ | √ | √ | √ | - | - |
| - Auto IMT+
(Auto IMT) | √ | √ | √ | √ | √ | - | - |
| - Elastoscan | √ | √ | √ | √ | √ | - | - |
| - Panoramic | √ | √ | √ | √ | √ | - | - |
| - 3D Imaging
(Volume Data
Acquisition) | √ | √ | √ | √ | √ | - | - |
| - 3D Imaging
presentation | | | | | | - | - |
| 3D Cine/4D Cine | √ | √ | √ | √ | √ | - | - |
| - 3D Rendering
MPR(Multi Planer
Render) | √ | √ | √ | √ | √ | - | - |
| - 3D XI | | | | | | | |
| MSV(Multi Slice
View)
Oblique View | √ | √ | √ | √ | √ | - | - |
| - 3D MXI | | | | | | | |
| Volume Slice, Mirror
View | √ | √ | √ | √ | √ | - | - |
| - Volume CT | √ | √ | √ | √ | √ | - | - |
| - 3D MagiCut | √ | √ | √ | √ | √ | - | - |
| - Volume Calculation
(VOCAL, XI
VOCAL) | √ | √ | √ | √ | √ | - | - |
| - XI STIC | √ | √ | √ | √ | √ | - | - |
| - HDVI | √ | √ | √ | √ | √ | - | - |
| - FRV | (2) | √ | √ | | | | |
| - ADVR | √ | √ | √ | √ | √ | - | - |
| - Clear Track | √ | | | | | √(3) | |
| - S-Detect | √ | | | | | | √(4) |
l ) The name of the feature is changed to ClearVision.
-
The name of the feature is changed to Realistic Vue.
-
Volume Navigation (Needle Tracking)
-
B-CAD
510(k) Summary / Statement Certification
ATTACHEMENT 1
4
RS80ADiagnostic Ultrasound System
-
- 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.
- 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,
The RS80A 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. RS80A, 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 RS80Ato be as safe, as effective, and performance is substantially equivalent to the predicate devices.
END of 510(K) Summary
510(k) Summary / Statement Certification
5
Image /page/5/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three curved lines that resemble a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Flealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2014
Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
Re: K141620
Trade/Device Name: RS80A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, IYO, ITX Dated: June 16, 2014 Received: June 17, 2014
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 Rs80a Diagnostic Ultrasound System, as described in your premarket notification: Transducer Model Number
| CA
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If your device is classified (see above) into cither class 11 (Special Controls) or class 111 (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.
6
Page 2-Mr. Job
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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
RS80A Diagnostic Ultrasound System
Indications for Use (Describe)
The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obsterics, Abdominal. Gynecology, Pediatric, Small Organ, Neonatal Cephalic. Adult Cephalic. Trans-rectal, Trans-vaginal. Muscular-Skeletal (Conventional. Superficial), Urology. Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Type of Use (Select one or both, as applicable)
2 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
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
8
510(k) No.:
Device Name: RS80ADiagnostic 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.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | N | N | N | N | Note 1 | Notes 2, 4, 7, 8, 9, 11, 14 | ||
| Abdominal (See Note 10) | N | N | N | N | N | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 12, 14 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | Note 1 | Notes 8, 9, 11 | ||
| Small Organ (See Note 5) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12. 14 | ||
| Neonatal Cephalic | N | N | N | N | Note 1 | Notes 8, 9 | ||
| Adult Cephalic | N | N | N | N | N | Note 1 | Notes 7 | |
| Trans-rectal | N | N | N | N | Note 1 | Notes 2,7, 8, 9, 11, 12 | ||
| Trans-vaginal | N | N | N | N | Note 1 | Notes 2, 7, 8, 9, 11, 12 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | ||
| Musculo-skel. (Superfic.) | N | N | N | N | Note 1 | Note 2, 5, 6. 7, 8. 9, 11, 14 | ||
| Intra-luminal | ||||||||
| Other (See Note 13) | N | N | N | N | Note 1 | Notes 2,7, 8, 9, 12 | ||
| Cardiac Adult | N | N | N | N | N | Note 1 | Notes 4, 7 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Notes 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 |
| Other (spec.) |
N= new indication. P= previously cleared by FDA. F= added under Appendix F.
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Coldr Dopper includes Power (Amplinder) Dopper
Nate 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PL+PW, B+PD+PW, B+C+M,Dusl/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
Note 2: Includes imaging for guidance of biopsy
Note 3; Includes infersility monitoring of follicle development
Note 4 Color M-mode
Note 5 : For example: thyroid, breast, scrowm and penis in adult, pediatic and nennalal palients
- Note 6: Abdominal organs and peripheral vessel
Note 7 Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note | 1: Panoramic imaging
Note 11: Panoramic
Note 12: Chauffeur
Note 12: FlastoScan
Note 13: Includes Urology/Prostate
Note 14: Cicar Track
Concurrence of Center for Devices und Radiological Heulth (CDRH) Prescription Use (Por 21 CFR 801 109)
Indication for use
page 2 of 15
9
510(k) No.:
Device Name: CA !-7A for use with RS80A
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/Obstetrics (See Note 3) | N | N | N | N | Note 1 | Notes 2,4,7,8,9,11,14 | ||
| Abdominal (See Note 10) | N | N | N | N | Note 1 | Notes 2,6,7,8,9,11,14 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| 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 (See Note 13) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication, P= previously cleared by FDA; E= added under Appendix L
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
ittonal Comments:
Colar Doppler includes Power (Anuplinde) Dopler
Nove : B+M, B+PW, B+C, B+DD, B+DPD, B+C'+PW, B+C+PW, B+C+PD+PW, B+PD+PW, B+C+M,I>xlV,Nxl/Qhad, B+C+CW, B+PD+CW. B+E, B+B/C
Note 2: Includes imaging for guidance of biopsy
Note 3. Includes inferiility monitoring of fullicle development
Nose 4: Calor M-mode
Note 4: Color M-hiode
Note 6 Abdominal organs and peripheral vessel
Note 7: Tissue Hamionic Imaging (THI)
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9. Spanal Compound Imaging
Note 10 Includes Renal, Gynecology/Pelvis
Note i 1 Panoramic imaging
Note | 2: ElastoScan
Note 13: Includes Urology/Prostate Note 14: Clenr Track
Concurrence of Center for Devices and Radiological Health (CDRH) Preseription Use (Per 21 CFR 801 109)
Indication for use
page 3 of 15
10
510(k) No.:
Device Name: C2-6 for use with RS80A
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/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | ||
| Abdominal(See Note 10) | P | P | P | P | Note 1 | Notes 2,6, 7, 8, 9, 11 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| 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 (See Note 13) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K 130803. I = added under Appendix Li
Additional Comments:
thouar Connineludes Power (Amplitude) Doppler
Color Dopper Includes Powel (Angliade) Dripler
Note 1: B+M, B+PW, B+C, B+PD, B+DY!), B+I'D, B+C+PW, B+PI>+PW, B+PID+PW, B+C+M.Iball(Xiad, B+C+CW, B+PD+CW. B+F. B+B/C
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infectibity monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrown and penis in adult, pediative and nevealal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis
Nolc 11: Ponoramic imaging
Nolc 12: FlastoScan
Note 13: Includes Urology/Prostate
Note 14: Clear Track
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)
Indication for use
page 4 of 15
11
510(k) No.:
Device Name: CF4-9for use with RS80A
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/Obstetrics (See Note 3) | |||||||||
| Abdominal(See Note 10) | P | P | P | P | Note 1 | Notes 8, 9, 11 | |||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Notes 8, 9, 11 | |||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | P | P | P | P | Note 1 | Notes 8, 9, 11 | |||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (See Note 13) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Notes 8, 9, 11 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K I 30803; L= added under Appendix L
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Dopper includes Power (Ampliude) Doper
Note I: B+M, B+PW, B+C, B+PD, B+DPD, B+C+PW, B+PD+PW, B+PD+PW, B+TD+PW, B+C+M,Izual/Quad, B+C+CW. B+PD+CW, B+E., B+B/C
Note 2: Includes imaging for guidance of biopsy
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 neonalal patients
Note 6: Abdominal organs and peripheral vesse!
Note 7: Tissue Harmonic Imaging {THI)
- Nole 8: 3D imaging
Note 9: Spanial Compound Imaging
Note 10: Includes Renal, Gynecolugy/Pelvis
Note 10: Includes Renal, Gynecology/Pelvis
- Note I I Panoranic unaging
- Note 12. FlastoScan
Note 13. Includes Urology/Prostate
Note 14 Clear Track
Concurrence of Center for Devices and Radiological Health {CDRH} Prescription Use (Per 21 CFR 801.109)
Indication for use
page 5 of 15
12
510(k) No.:
Device Name: E3-12Afor use with RS80A
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/Obstetrics (See Note 3) | P | P | P | P | Note I | Notes 2, 7, 8, 9 | ||
| Abdominal(See Note 10) | P | P | P | P | Note I | Notes 2, 7, 8, 9, 12 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 3) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | Note I | Notes 2, 7, 8, 9, 12 | ||
| Trans-vaginal | P | P | P | P | Note I | Notes 2, 7, 8, 9, 12 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | P | P | P | P | Note I | Notes 2, 7, 8, 9, 12 | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication: P= previously cleared by FDA K133329; E= added under Appendix E
Additional Comments:
Colar Doppler includes Power (Amplitude) Doppler
Cold Llopper Includes Power (Amplude) Lopper
Note I: B+M, B+PW, B+C, B+PD, B+DPI), B+TD, B+C'W, B+C+PW, B+PD+PW, B+TIX+PW, B+C+M,Dual/Quad. B+C+CW, B+PD+CW, B+E, B+B/C
Note 2: Includes imaging for guidance of biopsy
Note 2: Includes interior for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathytoid, breast, scroum and penis in adult, pediatic and necessar patiens
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Hannonic Imaging (THI)
- Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal. Ginecology/Pelvis
- Note II. Panoramic imaging
- Note 12: ElastoScan
Note 13. Includes Urology:140state Note 14 Clear Track
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)
Indication for use
page 6 of 15
13
510(k) No.:
Device Name: L3-12A for use with RS80A
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/Obstetrics (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) | P | P | P | P | Note I | Note 2, 5, 6, 7, 8, 9, 11, 12,14 | ||
| 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, 8, 9, 11, 14 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note I | Note 2, 5, 6, 7, 8, 9, 11, 14 | ||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note I | Note 2, 5, 6. 7, 8, 9, 11. 14 | |
| Other (spec.) |
N= new indication; P= previously cleared by:FDA K133329; L=added under Appendix L
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Colar Dopper includes Power (Amplinde) Dopper B+PD+CW. B+E, B+B/C
Note 2: Includes imaging for guidance of biopsy
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertitity montoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrolum and penis in adult, pediativ and neonalal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: Spatial Compound linaging
Note 10: Includes Renal, Gynecology/Pelvis
- Note II: Panoranic imaging
Note 12: ElastoScan
Note 13. Includes Urology/Prostate Note 14: Clear Track
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)
Indication for use
14
510(k) No .:
Device Name: L5-13 for use with RS80A
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/Obstetrics (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) | P | P | P | P | Note 1 | Note 2, 5, 6, 8, 7, 9, 11, 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, 8, 9, 11 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| 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, 8, 9, 11 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDAK 130803; L= added under Appendix L
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Dopper includes Power (Amphide) Dopper
Note I: B+M, B+PW, B+C, B+DPD, B+ID, B+C+PW, B+C+PW, B+PD+PW, B+DM)>+PW, B+C+M,Inal/Qhad, B+C+CW, B+PD+CW, B+E. B+B/C
Note 2: Includes imaging for guidance of biopsy.
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 neonalal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Nole 8: 3D imaging
Note 9: Spatial Compound Imaging
Nole 10: Includes Renal, Gynecology/Pelvis Note II: Panoramic imaging
- Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: Clear Track
Concurrence of Center for Devices and Radiological I Iralih (CDRH) Prescription Use (Per 21 CFR 801 109)
Indication for use
page 8 of 15
15
510(k) No.:
Device Name: L7-16 for use with RS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (includes simultaneous B-mode) | | | | | | Other
(Spec.) |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|---------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal(See Note 10) | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 |
| | 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, 8, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| 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, 8, 9, 11 |
| | Other (spec.) | | | | | | | |
N= new indication: P= previously cleared by FDA K130803: I:= added under Appendix Li
Additional Comments:
.
Color Doppler includes Power (Amplitude) Doppler
itional Comments:
Color Dopler includes Power (Ampliude) Doppler
Nue 1 B+M, B+PW, B+C, B+I1), B+ID!1), B+I'D, B+C'W, B+C+IVW, B+CDPD-I'W, B+C+M,Mall(Viad, B+C+CW, H-PD-CW, B-F., B+BK
Note 3. Includes imaging for gindance of biopsy
Note 3. Includes infertility montoring of folliate development
Note 4: Color M-mode
Note 5 For example: Untuid, parathyroid, breast, scrown and penis in adult, pediatre and newatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spaijal Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13 Includes Urology/Prostale
Note 14: Clear Track
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Usc (Per 21 CFR 801.109)
Indication for use
page 9 of 15
16
510(k) No .:
Device Name: LA2-9A for use with RS80A
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) | ਰ | M | PWD | CWD | Color | |||||
| Doppler | Combined" | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| FetaliObsteiries (See Note 3) | ||||||||||
| Abdominal(Sec Note 10) | 19 | P | p | p | Note I | Note 2, 5, 6, 7, 8, 9, 11 | ||||
| Intra-operative (Sec Note 6) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Fetal Imaging | Laparoscopic | |||||||||
| Other | ||||||||||
| ધ | Pediatric | |||||||||
| Small Organ (Ser Note 3) | ]> | P | p | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-reclal | ||||||||||
| Trans-vagnal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Convent) | P | P | P | P | Note 1 | Note 2. 5. 6. 7. 8. 9. 11 | ||||
| Musculo-skel (Superfic.) | P | P | p | P | Note I | Note 2, 5, 6, 7, 8, 9, 11 | ||||
| Intra-luminal | ||||||||||
| Other (Sec Note 13) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pedialric | |||||||||
| Trans-csophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | Peripheral vessel | P | િ | p | p | Note 1 | Note 2, 5. 6, 7, 8, 9, 11 | |||
| Vessel | Other (spec.) |
N= new indication: P= previously cleared by FDA K 130803; I = added under Appendix 1:
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Cold Dopper intudies Povel (Anghiboer) Ropper
Note 1 B+M, B+PW, B+C, B+(1), B+DPL), B+C'+PW, R+P(1)-PW, B+(1)PD+PW, B+TD+PW, B+C+M,Lhall()xiad, B+C+CW, B+PD-CW.B+E. B+B/C
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 neconatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoraniic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prosiate Note 14: Clear Track
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801. 109)
Indication for use
page 10 of 15
17
510(k) No.:
Device Name: PE2-4 for use with RS80A
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/Obstetrics (See Note 3) | |||||||
| Abdominal(See Note 10) | P | P | P | P | P | Note 1 | Note 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 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| 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 K 130803; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Dopper includes Power (Amplitude) Dolpter
Note I: B+M, B+PW, B+C, B+PD, B+DPD, B+C+PW, B+PD+PW, B+PD+PW, B+PD+PW, B+C+M.Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
Note 2: Includes imaging for guidance of biopsy
Note 2: Includes infertility monitoring of biopsy
Note 3: Includes infertility monitoring of Follscle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrolum and penis in adult, pediation and neconatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) .
Note 8: 3D imaging
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoranic imaging
Note 12: FlastoScan
Note 13: Includes UrologyProstate Note 14: Clear Track
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)
Indication for use
page 11 of 15
18
510(k) No.:
Device Name: PM1-6A for use with RS80A
Intended Use. Diagnostic ultrasound imaging or third 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 Obstetrics (See Note 5) | |||||||
| Abdominal(See Note 10) | N | N | N | N | N | Note 1 | Note 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 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel (Convent.) | ||||||||
| Musculo-skel (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| 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) Dopplet
Cood Copier memors Power (video) B-DN), B-C-PM, B-HD-PW, B-DND-PW, B-C-M,Dual Oual Dual R-C-CW, B+PD+CW B+E, B+B4C
Note 2: Includes maging for guidance of bropsy
Note 3 Includes infertifity momtoring of folhele development
Note 4 Color M-mode
Nate 5 For example thytonit, parathyroid, breast, scrothim and penis in adult, pediative and nearens
Note 6: Abdominal organs and peripheral vessel
Note 7 Tissue Hamnonse Imaging (TIH)
Note S 3D maging
Note 9 Spanal Compound Imaging
Note 10 Includes Renal. GynecologyPelsis
Note 11 Panorame imaging
Note 12 FilastaScan
Note 13: Includes UrologyProstate
Note 14 Clear Track
Conventence of Center for Devices and Radiological Health (CDRH) Preserspuon Use (Per 21 CFR S01.109)
Indication for use
page 12 of 15
19
510(k) No .;
Device Name: V5-9for use with RS80A
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/Obstetrics (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 | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K133329; E= added under Appendix L
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Cold Dopper includes Power (Amplinac) Lopper
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+C+PW, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M,Dial/Quad, B+C+CW, B+PD+CW, B+F., B+B/C
Note 2: Includes imaging for guidance of biopsy
Note 2. Includes inferility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediator and necenatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Nole 8: 3D imaging
Note 9: Spatial Compound Imaging
Note ID: Includes Renal, Gynecology/Pelvis
Note II: Panoranic imaging
Noic 12: ElastoScan
Nov. 12. Enskede
11-17. Includer 11%
Note 13: Includes Urology/Prostate Note 14: Clear Track
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
Indication for use
page 13 of 15
20
510(k) No.:
Device Name: LV3-14Afor use with RS80A
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 Obstetrics (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) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
| 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, 8, 9, 11 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| 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, 8, 9, 11 | |
| Other (spec.) |
N= new indication: P= previously cleared by FDA K103397: L= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Color Doppler includes Pover (Amphiude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+C'+PW, B+PU+PW, B+PD+PW, B+PD+PW, B+C+M,Ixlal/Quad, B+C+CW. B+PD+CW, B+E, R+R/C
Note 2: Includes imaging for guidance of biopsy
Note 2 : Includes infertility monitoring of follich development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrown and penis in adult, pediatric and neverstal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal. Gynecology:Pelvis
Note || Panoranic imaging Nule 12: ElastoScan
Note 12: PlastoScan
Note 13: Includes Use
Note 13. Includes Urology Prostate Note 14 Clear Track
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
Indication for use
page 14 of 15
21
510(k) No.:
Device Name: CW6.0 for use with RS80A
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 Obstetrics (See Note 3) | |||||||
| Abdominal(See Note 10) | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| 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 (See Note 13) | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | ||||||
| Other (spec.) |
N= new indication; P= previously cleared by ['DAK 112339; L= added under Appendix L
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Cold Libert includes Power (Anipinde) Loppier
Novel : B+M, B+DV, B+C, B+PD, B+DPD, B+ID, B+C++W, B+PD+PW, B+PD+PW, B+C+M,InaliQuad, B+C+CW,
Novel : B+M, B+DPD, B+DPD, B+ID, B+PD+CW.B+E. B+B/C
Note 2. Includes imaging for guidance of biopsy
Note 3. Includes inferritity monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyrord, parathyroid, breast, scrolum and penis in adult, pediative and neconatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology:Pelvis
Note II Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prosiate
Note 14: Clear Track
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Pcr 21 C'FR 80). 109)
Indication for use
page 15 of 15