The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for Orion Digital Imaging System.
| Device ID | K012490 |
| 510k Number | K012490 |
| Device Name: | ORION DIGITAL IMAGING SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Contact | Ralph J Flatau |
| Correspondent | Ralph J Flatau INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-03 |
| Decision Date | 2002-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854344007122 | K012490 | 000 |
| 00854344007115 | K012490 | 000 |
| 00854344007108 | K012490 | 000 |
| 00854344007092 | K012490 | 000 |
| 00854344007085 | K012490 | 000 |