FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STINGRAY DR, MODEL 1
K Number: K992794
·
Decision Nov 9, 1999
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
14
Review Days
82
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
- STINGRAY DR, MODEL 1
- K Number
- K992794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infimed, Inc.
- Date Received
- August 19, 1999
- Decision Date
- November 9, 1999
- 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 Infimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112180 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) | Aug 10, 2011 | Substantially Equivalent |
| K111344 | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) | Jun 10, 2011 | Substantially Equivalent |
| K103416 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM | Mar 17, 2011 | Substantially Equivalent |
| K101833 | INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 | Jul 23, 2010 | Substantially Equivalent |
| K093066 | I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 | Mar 16, 2010 | Substantially Equivalent |
| K012490 | ORION DIGITAL IMAGING SYSTEM | Feb 12, 2002 | Substantially Equivalent |
| K992392 | RTLX | Mar 31, 2000 | Substantially Equivalent |
| K992575 | CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 | Oct 7, 1999 | Substantially Equivalent |
| K962422 | INFIMED DENTAL SYSTEM | Sep 11, 1997 | Substantially Equivalent |
| K963037 | PATRIOT | Sep 27, 1996 | Substantially Equivalent |