FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLATO RADIATION THERAPY PLANNING SYSTEM
K Number: K921991
·
Decision Nov 27, 1992
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
11
Review Days
213
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Basic Information
- Device Name
- PLATO RADIATION THERAPY PLANNING SYSTEM
- K Number
- K921991
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nucletron-Oldelft Corp.
- Date Received
- April 28, 1992
- Decision Date
- November 27, 1992
- 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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| K915622 | PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM | Sep 25, 1992 | Substantially Equivalent |
| K911612 | NUCLETRON PLANNING SYSTEM | Jun 13, 1991 | Substantially Equivalent |
| K902533 | PULSED SELECTRON | Oct 12, 1990 | Substantially Equivalent |
| K864210 | MICROSELECTRON-HDR (HIGH DOSE RATE) | Nov 26, 1986 | Substantially Equivalent |
| K853912 | MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS | May 21, 1986 | Substantially Equivalent |
| K852842 | SELECTRON HDR REMOTE AFTERLOADER | Jan 10, 1986 | Substantially Equivalent |