The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Universal Cylinder Applicator Family.
| Device ID | K193240 |
| 510k Number | K193240 |
| Device Name: | Universal Cylinder Applicator Family |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | Varian Medical Systems, Inc. 911 Hansen Way Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc. 911 Hansen Way Palo Alto, CA 94304 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-25 |
| Decision Date | 2020-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389027909 | K193240 | 000 |
| 00816389027824 | K193240 | 000 |
| 00816389027831 | K193240 | 000 |
| 00816389027848 | K193240 | 000 |
| 00816389027855 | K193240 | 000 |
| 00816389027862 | K193240 | 000 |
| 00816389027879 | K193240 | 000 |
| 00816389027886 | K193240 | 000 |
| 00816389027893 | K193240 | 000 |
| 00816389027817 | K193240 | 000 |