The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17g).
| Device ID | K152761 |
| 510k Number | K152761 |
| Device Name: | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 2101 4TH AVE, SUITE 100 Seattle, WA 98121 |
| Contact | Marcia Page |
| Correspondent | Marcia Page VARIAN MEDICAL SYSTEMS, INC. 2101 4TH AVE, SUITE 100 Seattle, WA 98121 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-24 |
| Decision Date | 2015-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011006047 | K152761 | 000 |
| 00850011006139 | K152761 | 000 |