The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for I5 Digital X-ray Imaging System (with Flaatz 560).
| Device ID | K111344 |
| 510k Number | K111344 |
| Device Name: | I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Contact | Catherine Mulcahy |
| Correspondent | Catherine Mulcahy INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-12 |
| Decision Date | 2011-06-10 |
| Summary: | summary |