The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Mammosource High Dose Rate (hdr) Remote Afterloader.
Device ID | K040541 |
510k Number | K040541 |
Device Name: | MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-02 |
Decision Date | 2004-03-22 |
Summary: | summary |