The following data is part of a premarket notification filed by Impac Medical Systems, Inc. with the FDA for Imagert.
Device ID | K942346 |
510k Number | K942346 |
Device Name: | IMAGERT |
Classification | Accelerator, Linear, Medical |
Applicant | IMPAC MEDICAL SYSTEMS, INC. 209 HAMILTON AVE. Palo Alto, CA 94301 |
Contact | Joseph K Jachnowski |
Correspondent | Joseph K Jachnowski IMPAC MEDICAL SYSTEMS, INC. 209 HAMILTON AVE. Palo Alto, CA 94301 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-16 |
Decision Date | 1995-05-15 |