The following data is part of a premarket notification filed by Icrco Inc. with the FDA for Idr.
| Device ID | K082450 |
| 510k Number | K082450 |
| Device Name: | IDR |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | ICRCO INC. 2580 WEST 237TH STREET Torrance, CA 90505 |
| Contact | Thomas Chaney |
| Correspondent | Thomas Chaney 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 | 2008-08-25 |
| Decision Date | 2009-06-30 |