FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPERATING ARM SYSTEM (OAS)
K Number: K951262
·
Decision Nov 13, 1995
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
12
Review Days
237
Basic Information
- Device Name
- OPERATING ARM SYSTEM (OAS)
- K Number
- K951262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RADIONICS SOFTWARE APPLICATIONS, INC.
- Date Received
- March 21, 1995
- Decision Date
- November 13, 1995
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by RADIONICS SOFTWARE APPLICATIONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K990326 | OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII | Mar 4, 1999 | Substantially Equivalent |
| K974602 | OPTICAL TRACKING SYSTEM (OTS) | Apr 21, 1998 | Substantially Equivalent |
| K972905 | XPLAN-1 | Oct 28, 1997 | Substantially Equivalent |
| K964801 | OPTICAL TRACKING SYSTEM (OTS) | Jun 2, 1997 | Substantially Equivalent |
| K961844 | OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] | Oct 23, 1996 | Substantially Equivalent |
| K962155 | GILL-THOMAS-COSMAN(GTC) DENTAL TRAY | Aug 22, 1996 | Substantially Equivalent |
| K960071 | IMAGEFUSION | Apr 17, 1996 | Substantially Equivalent |
| K944463 | CRW-1 SYSTEM | Oct 26, 1995 | Substantially Equivalent |
| K953482 | XKNIFE-3 | Oct 25, 1995 | Substantially Equivalent |
| K946252 | STEREOPLAN | Mar 14, 1995 | Substantially Equivalent |