The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Titanium Fletcher-style Applicator Set-defined Geometry.
| Device ID | K120731 |
| 510k Number | K120731 |
| Device Name: | TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY |
| 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 | 2012-03-09 |
| Decision Date | 2012-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816389023888 | K120731 | 000 |
| 00810563022377 | K120731 | 000 |
| 00810563022384 | K120731 | 000 |
| 00810563022391 | K120731 | 000 |
| 00810563022209 | K120731 | 000 |
| 00816389021648 | K120731 | 000 |
| 00816389021785 | K120731 | 000 |
| 00816389021792 | K120731 | 000 |
| 00816389021808 | K120731 | 000 |
| 00816389021815 | K120731 | 000 |
| 00816389023703 | K120731 | 000 |
| 00816389023710 | K120731 | 000 |
| 00816389023727 | K120731 | 000 |
| 00816389023734 | K120731 | 000 |
| 00816389023741 | K120731 | 000 |
| 00816389023758 | K120731 | 000 |
| 00816389023765 | K120731 | 000 |
| 00816389023772 | K120731 | 000 |
| 00810563022360 | K120731 | 000 |