FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAMMA GUIDANCE SYSTEM
K Number: K961321
·
Decision Feb 10, 1997
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
29
Applicant Total
2
Review Days
311
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Basic Information
- Device Name
- GAMMA GUIDANCE SYSTEM
- K Number
- K961321
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1320
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Radiation Monitoring Devices, Inc.
- Date Received
- April 5, 1996
- Decision Date
- February 10, 1997
- Product Code
- IZD
- 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 |
|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | FDA class 1 | Radiology |
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Other Clearances by Radiation Monitoring Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983768 | MODIFICATION TO GAMMA GUIDANCE SYSTEM | Jul 2, 1999 | Substantially Equivalent |