The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Standard Imaging E.imrt Calculator.
| Device ID | K040688 |
| 510k Number | K040688 |
| Device Name: | STANDARD IMAGING E.IMRT CALCULATOR |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-16 |
| Decision Date | 2004-05-11 |
| Summary: | summary |