FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IDR
K Number: K082450
·
Decision Jun 30, 2009
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
5
Review Days
309
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
- IDR
- K Number
- K082450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Icrco, Inc.
- Date Received
- August 25, 2008
- Decision Date
- June 30, 2009
- 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