The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Gammamedplus Ix Brachytherapy Afterloader, Gammamedplus 3/24 Ix Brachytherapy Afterloader.
| Device ID | K120993 |
| 510k Number | K120993 |
| Device Name: | GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, INC. 3100 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 | 2012-04-02 |
| Decision Date | 2012-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389027329 | K120993 | 000 |
| 00816389027312 | K120993 | 000 |
| 00816389020412 | K120993 | 000 |
| 00816389020405 | K120993 | 000 |
| 00816389020399 | K120993 | 000 |
| 00816389020382 | K120993 | 000 |
| 00816389028845 | K120993 | 000 |