FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL FLUROGRAPHIC IMAGING SYSTEM
K Number: K813217
·
Decision Dec 29, 1981
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
42
Review Days
50
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DIGITAL FLUROGRAPHIC IMAGING SYSTEM
- K Number
- K813217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Diasonics, Inc.
- Date Received
- November 9, 1981
- Decision Date
- December 29, 1981
- Product Code
- JAA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAA), ordered by most recent decision date.
Nexus DRF Digital X-ray Imaging System
FDA 510(k)
FDA Class 2
·Radiology
Insight Enhanced DRF (EN-1002-01)
FDA 510(k)
FDA Class 2
·Radiology
Soteria E-View
FDA 510(k)
FDA Class 2
·Radiology
Adora DRFi (04550010)
FDA 510(k)
FDA Class 2
·Radiology
TRIDENT Mobile Fluoroscopy System
FDA 510(k)
FDA Class 2
·Radiology
ProxiDiagnost N90 / Precision CRF (706110, 706400)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Diasonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962662 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM | Jan 2, 1997 | Substantially Equivalent |
| K924079 | CFM-800 COLOR FLOW MAPPING SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K911435 | CPA/3.5 MHZ PROBE | Sep 11, 1992 | Substantially Equivalent |
| K905200 | SACA, 3.5 MHZ PROBE | Apr 2, 1992 | Substantially Equivalent |
| K903562 | CW DOPPLER 2.25 MHZ PROBE | Mar 2, 1992 | Substantially Equivalent |
| K903984 | CW DOPPLER/4.5 MHZ | Jun 14, 1991 | Substantially Equivalent |
| K896637 | ACCESS(TM), SOFTWARE RELEASE 4.11P | Jan 22, 1990 | Substantially Equivalent |
| K893518 | MT/S SOFTWARE RELEASE 5.0. | Oct 27, 1989 | Substantially Equivalent |
| K894290 | ACCESS TM | Sep 7, 1989 | Substantially Equivalent |
| K893881 | ACCESS TM | Jun 23, 1989 | Substantially Equivalent |