FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVA FA DR SYSTEM
K Number: K133782
·
Decision Mar 21, 2014
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
26
Review Days
99
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
- NOVA FA DR SYSTEM
- K Number
- K133782
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sedecal., Sa.
- Date Received
- December 12, 2013
- Decision Date
- March 21, 2014
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQB), ordered by most recent decision date.
VIVIX-S 4386W (FXRD-4386WA)
FDA 510(k)
FDA Class 2
·Radiology
Universal 1417PI
FDA 510(k)
FDA Class 2
·Radiology
Lux HD 2530 detector (Lux HD 2530)
FDA 510(k)
FDA Class 2
·Radiology
Yushan X-Ray Flat Panel Detector
FDA 510(k)
FDA Class 2
·Radiology
SKR 3000
FDA 510(k)
FDA Class 2
·Radiology
Wireless/ Wired X-Ray Flat Panel Detectors
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Sedecal., Sa.
| K Number | Device Name | ||
|---|---|---|---|
| K232185 | SM-IV | Aug 21, 2023 | Substantially Equivalent |
| K222951 | SM-V | Nov 21, 2022 | Substantially Equivalent |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | Jul 18, 2022 | Substantially Equivalent |
| K212291 | PHOENIX | Sep 14, 2021 | Substantially Equivalent |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | Feb 1, 2021 | Substantially Equivalent |
| K202293 | Radiographic System Challenge X | Oct 7, 2020 | Substantially Equivalent |
| K192936 | Soltus 500 | Nov 15, 2019 | Substantially Equivalent |
| K192011 | PhoeniX | Sep 25, 2019 | Substantially Equivalent |
| K191813 | MobileDiagnost wDR 2.2 | Aug 2, 2019 | Substantially Equivalent |
| K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | Jan 26, 2018 | Substantially Equivalent |