The following data is part of a premarket notification filed by Scandia Corporation with the FDA for Scandia-45 Gamma Camera System.
| Device ID | K101391 |
| 510k Number | K101391 |
| Device Name: | SCANDIA-45 GAMMA CAMERA SYSTEM |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SCANDIA CORPORATION 10200 DENNIS DRIVE SUITE 5 Urbandale, IA 50322 |
| Contact | David Askew |
| Correspondent | David Askew SCANDIA CORPORATION 10200 DENNIS DRIVE SUITE 5 Urbandale, IA 50322 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-18 |
| Decision Date | 2010-08-04 |
| Summary: | summary |