The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Standard Imaging Imsure Brachy Qa Software, Model 91331.
| Device ID | K082773 |
| 510k Number | K082773 |
| Device Name: | STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 |
| Classification | Accelerator, Linear, Medical |
| Applicant | STANDARD IMAGING, INC. 3120 DEMING WAY Middleton, WI 53562 -1461 |
| Contact | Raymond Riddle |
| Correspondent | Raymond Riddle STANDARD IMAGING, INC. 3120 DEMING WAY Middleton, WI 53562 -1461 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2008-11-19 |
| Summary: | summary |