FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORION DIGITAL IMAGING SYSTEM
K Number: K012490
·
Decision Feb 12, 2002
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
300
Applicant Total
14
Review Days
193
Basic Information
- Device Name
- ORION DIGITAL IMAGING SYSTEM
- K Number
- K012490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INFIMED, INC.
- Date Received
- August 3, 2001
- Decision Date
- February 12, 2002
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OWB), ordered by most recent decision date.
Cios Alpha; Cios Flow
FDA 510(k)
FDA Class 2
·Radiology
TAVIPILOT
FDA 510(k)
FDA Class 2
·Radiology
EXTRON 3; EXTRON 5; EXTRON 7
FDA 510(k)
FDA Class 2
·Radiology
Diagnostic X-ray System
FDA 510(k)
FDA Class 2
·Radiology
MasteRad MiniX Mobile Digital Imaging System (Mini-X)
FDA 510(k)
FDA Class 2
·Radiology
Persona C HR
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 |
| K992392 | RTLX | Mar 31, 2000 | Substantially Equivalent |
| K992794 | STINGRAY DR, MODEL 1 | Nov 9, 1999 | 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 |