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 |