The following data is part of a premarket notification filed by Imaging Dynamics Company Ltd. with the FDA for Innovaxion Fp, Innovaxion Fp 1600 Plus, Magellan.
| Device ID | K111098 |
| 510k Number | K111098 |
| Device Name: | INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | IMAGING DYNAMICS COMPANY LTD. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm IMAGING DYNAMICS COMPANY LTD. 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-20 |
| Decision Date | 2011-05-27 |
| Summary: | summary |