FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSELECTRON-HDR VERSION 2
K Number: K953946
·
Decision Aug 13, 1996
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
11
Review Days
358
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Basic Information
- Device Name
- MICROSELECTRON-HDR VERSION 2
- K Number
- K953946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nucletron-Oldelft Corp.
- Date Received
- August 21, 1995
- Decision Date
- August 13, 1996
- Product Code
- JAQ
- 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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
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Other Clearances by Nucletron-Oldelft Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953831 | N 800 HF | Sep 8, 1995 | Substantially Equivalent |
| K925956 | MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT | Nov 19, 1993 | Substantially Equivalent |
| K926407 | MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM | Mar 31, 1993 | Substantially Equivalent |
| K921991 | PLATO RADIATION THERAPY PLANNING SYSTEM | Nov 27, 1992 | Substantially Equivalent |
| 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 |