The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Dosimetrist Workspace V2.7 Model: 1056864.
| Device ID | K101119 |
| 510k Number | K101119 |
| Device Name: | SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520 |
| Contact | Christine Dunbar |
| Correspondent | Christine Dunbar SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-21 |
| Decision Date | 2010-06-16 |
| Summary: | summary |