FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTICAL TRACKING SYSTEM (OTS)
K Number: K974602
·
Decision Apr 21, 1998
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
12
Review Days
133
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Basic Information
- Device Name
- OPTICAL TRACKING SYSTEM (OTS)
- K Number
- K974602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics Software Applications, Inc.
- Date Received
- December 9, 1997
- Decision Date
- April 21, 1998
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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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 |
| 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 |
| K951262 | OPERATING ARM SYSTEM (OAS) | Nov 13, 1995 | 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 |