The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Standard Imaging Hdr 1000 Ion Chamber.
| Device ID | K922554 |
| 510k Number | K922554 |
| Device Name: | STANDARD IMAGING HDR 1000 ION CHAMBER |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | STANDARD IMAGING, INC. 6213 MIDDLETON SPRINGS DRIVE, SUITE 205, P.O. BOX 352 Middleton, WI 53562 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle STANDARD IMAGING, INC. 6213 MIDDLETON SPRINGS DRIVE, SUITE 205, P.O. BOX 352 Middleton, WI 53562 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-29 |
| Decision Date | 1992-08-24 |