The following data is part of a premarket notification filed by Varian Medical Systems Inc with the FDA for Anchored Beacon(r) Transponder, Anchored Transponder, Beacon Care Package - Lung.
Device ID | K170570 |
510k Number | K170570 |
Device Name: | Anchored Beacon(R) Transponder, Anchored Transponder, Beacon Care Package - Lung |
Classification | Accelerator, Linear, Medical |
Applicant | Varian Medical Systems Inc 3100 Hansen Way Palo Alto, CA 94304 -1038 |
Contact | Lisa Levine |
Correspondent | Lisa Levine Varian Medical Systems Inc 3100 Hansen Way Palo Alto, CA 94304 -1038 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-27 |
Decision Date | 2018-04-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850011006122 | K170570 | 000 |