FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RFA-7 RADIATION FIELD ANALYZER
K Number: K845007
·
Decision Jul 1, 1985
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
7
Applicant Total
86
Review Days
187
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Basic Information
- Device Name
- RFA-7 RADIATION FIELD ANALYZER
- K Number
- K845007
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1940
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Varian Assoc., Inc.
- Date Received
- December 26, 1984
- Decision Date
- July 1, 1985
- Product Code
- LHO
- 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 |
|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | FDA class 1 | Radiology |
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| K980601 | VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER | Oct 21, 1998 | Substantially Equivalent |
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| K955774 | VARIS PORTALVISION | Mar 15, 1996 | Substantially Equivalent |
| K954467 | CADPLAN BT | Mar 15, 1996 | Substantially Equivalent |
| K943224 | VARIAN MULTILEAF COLLIMATOR | Feb 2, 1996 | Substantially Equivalent |