FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
K Number: K062647
·
Decision Oct 20, 2006
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
8
Review Days
44
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Basic Information
- Device Name
- E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
- K Number
- K062647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Omega Medical Imaging, Inc.
- Date Received
- September 6, 2006
- Decision Date
- October 20, 2006
- 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 |
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Other Clearances by Omega Medical Imaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100102 | CS-SERIES-FP | Aug 31, 2010 | Substantially Equivalent |
| K093572 | R650 QDASM COLLIMATOR | Feb 3, 2010 | Substantially Equivalent |
| K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) | May 18, 2007 | Substantially Equivalent |
| K050092 | R605 FACS COLLIMETER | Jan 31, 2005 | Substantially Equivalent |
| K990055 | B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 | Feb 2, 1999 | Substantially Equivalent |
| K970947 | B-350 CEILING MOUNTED C-POSITIONER | May 14, 1997 | Substantially Equivalent |
| K902005 | MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE | Sep 20, 1990 | Substantially Equivalent |