Radiotherapeutics Corp.
Sunnyvale, CA, US
Radiotherapeutics Corp. appears in FDA device records in Sunnyvale, CA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Radiotherapeutics Corp. between 1995 and 2002. The busiest year on record is 1996, with 3. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 2 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011220 | LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE | GEI | Substantially Equivalent | |
| K012315 | LEVEEN ELECTRODE | GEI | Substantially Equivalent | |
| K000241 | RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR | GEI | Substantially Equivalent | |
| K982556 | LEVEEN NEEDLE ELECTRODE | GEI | Unknown | |
| K000032 | LEVEEN NEEDLE ELECTRODE | GEI | Substantially Equivalent | |
| K982854 | MR COMPATIBLE LEVEEN NEEDLE ELECTRODE | GEI | Substantially Equivalent | |
| K981672 | RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR | GEI | Substantially Equivalent | |
| K972441 | RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 | GEI | Substantially Equivalent | |
| K962313 | MODIFIED LEVEEN NEEDLE ELECTRODE | JOS | Substantially Equivalent | |
| K962386 | SENSOR SHEATH TS1 | FLL | Substantially Equivalent | |
| K955144 | RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000 | GEI | Substantially Equivalent | |
| K950347 | LEVEEN NEEDLE ELECTRODE(TM) | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain