(9 days)
Not Found
No
The document describes a standard ultrasound system and does not mention AI, ML, or any related technologies in the device description, intended use, or any other section.
No.
The device is described as a "general purpose diagnostic ultrasound system" and is used for "ultrasound evaluation," indicating its purpose is diagnosis rather than therapy.
Yes
The "Device Description" explicitly states, "The SuperNova is a general purpose diagnostic ultrasound system." The "Intended Use / Indications for Use" section also outlines its use for "ultrasound evaluation" of various anatomical sites, which is a diagnostic purpose.
No
The device description explicitly details hardware components including a Personal Display Unit, Imaging Unit, transducer module, and docking station, which are physical parts of the system, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the SuperNova is a diagnostic ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes the anatomical sites and patient types for which the ultrasound is used for evaluation. This is consistent with an imaging device, not an IVD.
- Device Description: The description details the physical components of an ultrasound system (Personal Display Unit, Imaging Unit, transducer module, docking station).
- Input Imaging Modality: The input modality is explicitly stated as Ultrasound.
Therefore, the SuperNova is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transducer: SuperNova System (Union of all Transducer Types):
Ophthalmic, Fetal, Abdominal, Intra-operative (Specify), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Conventional), Musculo-skel. (Superficial), Intra-luminal, Other (Specify), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Specify), Peripheral Vessel, Other (Specify).
SuperNova System with Curvilinear Transducer PN 84001:
Fetal, Abdominal6, Pediatric, Peripheral Vessel.
SuperNova System with Phased (Sector) Array Transducer PN 84004:
Fetal, Abdominal6, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric.
SuperNova System with Endo-Vaginal Transducer PN 84002:
Fetal, Trans-rectal, Trans-vaginal.
SuperNova System with Linear Transducer PN 84003:
Fetal, Abdominal6, Intra-operative (Specify)7, Intra-operative (Neuro), Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Neonatal Cephalic, Peripheral Vessel.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
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.
Mentions image processing
Signals received from the transducer module are digitized and preprocessed.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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, Ophthalmic, Laparoscopic, Trans-urethral, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intra-luminal.
Indicated Patient Age Range
Fetal, Pediatric, Neonatal, Adult
Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Kozls5g
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. |
| 1061 Terra Bella Ave. | |
| Mountain View, CA 94043 | |
| Contact Persons: | Cheryl A. Blake |
| Director, Quality Assurance | |
| 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
1
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.
2
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
$\frac{C2^4}{S2^4}$
3
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".
4
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)
5
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 | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative | ||||||||
| (Specify)6 | N | N | N | N | N | N | ||
| Intra-operative | ||||||||
| (Neuro) | N | N | N | N | N | |||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| 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- | ||||||||
| 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
6
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 | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | ||
| Abdominal6 | N | N | N | N | N | N | ||
| Intra-operative | ||||||||
| (Specify) | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | ||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| 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
7
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 | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | N | |
| Abdominal6 | N | N | N | N | N | N | N | |
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Fetal Imaging | ||||||||
| & 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- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (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. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| 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
8
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 | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | N | ||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Specify)7 | ||||||||
| Intra-operative | ||||||||
| (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| Testes, etc.) | ||||||||
| Fetal Imaging | ||||||||
| & 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- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Trans-esoph. | |||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral 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)
Prescription Use
David A. Segner
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
Revision 3 SuperNova
9
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 | ||||||||
| (Track I Only) | Specific | |||||||
| (Track I & III) | B1 | M | PWD2 | CWD | Color | |||
| Doppler3 | Combined | |||||||
| Modes4 | Other5 | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | N | N | N | N | N | N | N |
| Abdominal6 | N | N | N | N | N | N | N | |
| Intra-operative | ||||||||
| (Specify)7 | N | N | N | N | N | N | N | |
| Intra-operative | ||||||||
| (Neuro) | N | N | N | N | N | |||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ | ||||||||
| (Thyroid, Breast, | ||||||||
| 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. | ||||||||
| (Conventional) | ||||||||
| Musculo-skel. | ||||||||
| (Superficial) | ||||||||
| Intra-luminal | ||||||||
| Other (Specify)8 | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. | ||||||||
| (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| 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