The following data is part of a premarket notification filed by Icrco Inc. with the FDA for Fusion Flat Panel.
| Device ID | K113449 |
| 510k Number | K113449 |
| Device Name: | FUSION FLAT PANEL |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ICRCO INC. 2580 WEST 237TH STREET Torrance, CA 90505 |
| Contact | Greg Wachtler |
| Correspondent | Greg Wachtler ICRCO INC. 2580 WEST 237TH STREET Torrance, CA 90505 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-06-14 |