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 | K120067 |
510k Number | K120067 |
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 | 2012-01-09 |
Decision Date | 2012-02-28 |
Summary: | summary |