The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Hdr 1000 Plus Well Chamber, Model 90008.
| Device ID | K060532 |
| 510k Number | K060532 |
| Device Name: | HDR 1000 PLUS WELL CHAMBER, MODEL 90008 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766 |
| Contact | Raymond Riddle |
| Correspondent | Raymond Riddle STANDARD IMAGING, INC. 7601 MURPHY DR. Middleton, WI 53562 -2766 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-28 |
| Decision Date | 2006-04-11 |
| Summary: | summary |