The following data is part of a premarket notification filed by Impac Medical Systems, Inc. with the FDA for Mosaiq Oncology Information System.
| Device ID | K141572 |
| 510k Number | K141572 |
| Device Name: | MOSAIQ ONCOLOGY INFORMATION SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | IMPAC MEDICAL SYSTEMS, INC. 100 MATHILDA PLACE, 5TH FLOOR Sunnyvale, CA 94086 |
| Contact | Kathryn Stinson |
| Correspondent | Kathryn Stinson IMPAC MEDICAL SYSTEMS, INC. 100 MATHILDA PLACE, 5TH FLOOR Sunnyvale, CA 94086 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2014-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858164002237 | K141572 | 000 |