FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
K Number: K994355
·
Decision Mar 22, 2000
Classifications
1
FEI Numbers
123
Registration Numbers
124
Same Product Code
717
Applicant Total
27
Review Days
90
Basic Information
- Device Name
- RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
- K Number
- K994355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SURGICAL NAVIGATION TECHNOLOGIES, INC.
- Date Received
- December 23, 1999
- Decision Date
- March 22, 2000
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by SURGICAL NAVIGATION TECHNOLOGIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K000246 | RADIOCAMERAS EXTRACRANIAL SYSTEM | Oct 20, 2000 | Substantially Equivalent |
| K992461 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Feb 22, 2000 | Substantially Equivalent |
| K992927 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Dec 29, 1999 | Substantially Equivalent |
| K993021 | METRX SYSTEM | Nov 10, 1999 | Substantially Equivalent |
| K992354 | SNT IMAGE ANALYSIS SYSTEM | Oct 12, 1999 | Substantially Equivalent |
| K991468 | IMMERGE IMAGE CORRELATION | Jul 6, 1999 | Substantially Equivalent |
| K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM | Apr 22, 1999 | Substantially Equivalent |
| K983670 | STEALTHSTATION SYSTEM | Jan 14, 1999 | Substantially Equivalent |
| K984000 | STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM | Jan 12, 1999 | Substantially Equivalent |
| K983397 | STEALTHSTATION TREATMENT GUIDANCE PLAFFORM | Dec 4, 1998 | Substantially Equivalent |