SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
Device Facts
| Record ID | K022858 |
|---|---|
| Device Name | SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM |
| Applicant | Novasonics, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 6, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal: Abdominal: Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Trans-esoph. (non-cardiac); Cardiac Adult; Cardiac Pediatric; Trans-esoph (Cardiac), Peripheral Vessel.
Device Story
SuperNova is a handheld, general-purpose diagnostic ultrasound system. It comprises a Personal Display Unit (PDU) with an integrated screen and control buttons, an Imaging Unit, and a docking station for charging and storage. The system utilizes removable transducer modules that contact the patient to transmit and receive ultrasound energy. Received signals are digitized and preprocessed by the Imaging Unit. The device supports B-mode, M-mode, Pulsed Wave Doppler (PWD), High Pulse Repetition Rate PWD (HPRF), Color Doppler, Directional Power Doppler, Power Doppler, and Harmonic imaging. Operated by physicians in clinical settings, the system provides real-time ultrasound images and interface data on the PDU screen. This output assists clinicians in diagnostic evaluation and fluid flow analysis, potentially improving patient management through non-invasive visualization of internal structures and hemodynamics.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on technological characteristics, intended use, and functional comparison to predicate devices. Bench testing, including acoustic output measurements, is required as a condition of clearance.
Technological Characteristics
Handheld diagnostic ultrasound system with removable transducers. Supports B-mode, M-mode, PWD, HPRF, Color Doppler, and Harmonic imaging. System includes a Personal Display Unit and Imaging Unit. Connectivity via docking station for battery charging. Sterilization requirements for transducers apply. Technical specifications for acoustic output are subject to post-clearance reporting.
Indications for Use
Indicated for qualified physicians performing diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, intra-operative (abdominal, thoracic, vascular, neuro), pediatric, small organ (thyroid, breast, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, trans-esophageal (non-cardiac/cardiac), cardiac (adult/pediatric), and peripheral vessel applications.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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# Attachment E: Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c). 510(k) Summary of Safety and effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMD 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
| Applicant Information: | |
|------------------------|----------------------------------------------------------------------|
| Date Prepared: | March 18, 2002 |
| Name: | Novasonics, Inc.<br>1061 Terra Bella Ave.<br>Mountain View, CA 94043 |
| Contact Persons: | Cheryl A. Blake<br>Director, Quality Assurance<br>Regulatory Affairs |
| Telephone Numbers: | 650-230-2715 |
| Fax Number: | 650-230-2818 |
| Device Information: | |
| Classification: | Class II |
| Trade Name: | Novasonics SuperNova Ultrasound System |
| Common Name: | Diagnostic Ultrasound System |
Nova Plus Diagnostic Ultrasound System Device Name:
| | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
The HDI 5000: K002003 and the GE LOGIC 9: K011188 Marketed Device(s):
Device Description: The SuperNova is a general purpose diagnostic ultrasound system. It consists of a Personal Display Unit approximately 4 inches wide and 3 inches high that can be held by the user in one hand and includes buttons for controlling the system and a screen that display ultrasound mages and user interface . The Imaging Unit can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmits and receives ultrasound energy
The docking station provides holders for the Personal Display Unit, the Imaging Unit, and transducer modules, as well as battery chargers.
Indications For Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal: Abdominal: Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans
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vaginal; Trans-esoph. (non-cardiac); Cardiac Adult; Cardiac Pediatric; Trans-esoph (Cardiac), Peripheral Vessel.
Comparison with Predicate Device: The SuperNova ultrasound system equipped with Doppler and Harmonic imaging modes is substantially equivalent from both a transducer and user point of view to the Phillips ATL HDT® 5000 or the GE Logiq 9™ systems, that are currently in commercial distribution in the United States. Since the SuperNova unit has intended uses and functional modes that are a subset of these approved devices it is felt that the SuperNova unit meets the criteria for substantial equivalence as required for 510(k) filling.
The technological characteristics utilized in design, construction, and materials are similar, and have the same intended uses and basic operating modes as the predicate devices.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Druq Administrat 9200 Corporate Boulevaro Rockville MD 20850
Novasonics, Inc. % Mr. Mark Job Program Manager TÜV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K022858
Trade Name: SuperNova Diagnostic Ultrasound Scanning System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: August 23, 2002 Received: August 28, 2002
## Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the SuperNova Diagnostic Ultrasound Scanning System, as described in your premarket notification:
## Transducer Model Number
\$\frac{C*2^4}{S*2^4}\$
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If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
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If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212. · . ..
Sincerely yours,
David A. Lyon
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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K 0.22858
### Draft
# SuperNova System with Doppler and Harmonic Imaging Modes
Transducer: SuperNova System (Union of all Transducer Types)
I ransucct. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|---------------------------------------------------|----|---|------|-----|-------------------|--------------------|--------|
| General<br>(Track I Only) | Specific<br>(Track I & III) | B1 | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | N | N | N | N |
| | Abdominal | N | N | N | N | N | N | N |
| | Intra-operative<br>(Specify)6 | N | N | N | | N | N | N |
| | Intra-operative<br>(Neuro) | N | | N | | N | N | N |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N |
| | Small Organ<br>(Thyroid, Breast,<br>Testes, etc.) | N | N | N | | N | N | N |
| Fetal Imaging | Neonatal Cephalic | N | N | N | N | N | N | N |
| & Other | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | N | N | N | | N | N | N |
| | Trans-vaginal | N | N | N | | N | N | N |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel. | | | | | | | |
| | (Conventional) | | | | | | | |
| | Musculo-skel. | | | | | | | |
| | (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N |
| | Cardiac Pediatric | N | N | N | N | N | N | N |
| Cardiac | Trans-esoph. | | | | | | | |
| | (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral | Peripheral Vessel | N | N | N | | N | N | N |
| Vessel | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
1 Includes B-Mode and Harmonic imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
Color M-Mode (CM)
Intraoperative includes abdominal, thoracic (cardiac) and vascular (PV (Division Sign-Off)
David C. Hyam
(Division Sign-Off)
*Prescription Use*
Division of Reproductive, Abdomina and Radiological D 510(k) Number
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Draft
# . SuperNova System with Curvilinear Transducer PN 84001
System: SuperNova System with Doppler and Harmonic Imaging modes
Transducer: C2
.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------------|-------------------|---|------|-----|-------------------|--------------------|--------|
| General<br>(Track I Only) | Specific<br>(Track I & III) | B1 | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | N |
| | Abdominal6 | N | N | N | | N | N | N |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | N | N |
| | Small Organ<br>(Thyroid, Breast,<br>Testes, etc.) | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Trans-esoph.<br>(Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | N | N | N | | N | N | N |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
1 Includes B-Mode and Harmonic imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
*Prescription Use*
Daniel A. Segner
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Dev 510(k) Number _
Revision 3 SuperNova
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Draft · .
SuperNova System with Phased (Sector) Array Transducer PN 84004
System: SuperNova System with Doppler and Harmonic Imaging modes
Transducer: S2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------------|-------------------|---|------|-----|-------------------|--------------------|--------|
| General<br>(Track I Only) | Specific<br>(Track I & III) | B1 | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | N | N | N | N |
| | Abdominal6 | N | N | N | N | N | N | N |
| | Intra-operative<br>(Specify)7 | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N |
| | Small Organ<br>(Thyroid, Breast,<br>Testes, etc.) | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | N | N | N | N | N | N | N |
| | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N |
| | Cardiac Pediatric | N | N | N | N | N | N | N |
| | Trans-esoph.<br>(Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
I Includes B-Mode and Harmonic imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
*Prescription Use* ✓
Daniel A. Lyons
(Division Sign-Off) Division of Reproductive, Abdominal, Division of Reproductive and Radiological Devigo
510k) Number 510(k) Number _
Revision 3 SuperNova
12
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Draft
SuperNova System with Endo-Vaginal Transducer PN 84002
System: SuperNova System with Doppler and Harmonic Imaging modes
Transducer: EV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|---------------------------------------------------|----|---|------|-----|-------------------|--------------------|--------|
| General<br>(Track I Only) | Specific<br>(Track I & III) | B1 | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | N | | N | N | N |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify)7 | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ<br>(Thyroid, Breast,<br>Testes, etc.) | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N |
| | Trans-vaginal | N | N | N | | N | N | N |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Trans-esoph.<br>(Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel<br>Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
1 Includes B-Mode and Harmonic imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
*Prescription Use*
David A. Segner
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
Revision 3 SuperNova
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## Draft -
# SuperNova System with Linear Transducer PN 84003
System: SuperNova System with Doppler and Harmonic Imaging modes Transducer: L's
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|---------------------------------------------------|-------------------|---|------|-----|-------------------|--------------------|--------|
| General<br>(Track I Only) | Specific<br>(Track I & III) | B1 | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5 |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N | N | N | N | N | N | N |
| | Abdominal6 | N | N | N | N | N | N | N |
| | Intra-operative<br>(Specify)7 | N | N | N | N | N | N | N |
| | Intra-operative<br>(Neuro) | N | | N | | N | N | N |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N |
| | Small Organ<br>(Thyroid, Breast,<br>Testes, etc.) | N | N | N | N | N | N | N |
| | Neonatal Cephalic | N | N | N | N | N | N | N |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify)8 | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph.<br>(Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral Vessel | N | N | N | N | N | N | N |
| | Other (Specify) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
1 Includes B-Mode and Harmonic imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative includes abdominal, thoracic (cardiac) and vascular (PV)
*Prescription Use* ✓
David A. Symm
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
Revision 3 SuperNova
