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.
| Device ID | K140823 |
| 510k Number | K140823 |
| Device Name: | PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS, INC. 2101 4th Ave Ste 100 Seattle, WA 98121 |
| Contact | Lisa Levine |
| Correspondent | Lisa Levine VARIAN MEDICAL SYSTEMS, INC. 2101 4th Ave Ste 100 Seattle, WA 98121 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011006030 | K140823 | 000 |