The following data is part of a premarket notification filed by Icrco Inc. with the FDA for Icrco 3600m.
| Device ID | K122510 |
| 510k Number | K122510 |
| Device Name: | ICRCO 3600M |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| 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 | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-17 |
| Decision Date | 2013-04-26 |