The following data is part of a premarket notification filed by Orex Computed Radiography Ltd with the FDA for Kodak Point Of Care Cr 120, Kodak Point Of Care Cr 140, Kodak Point Of Care Cr 260.
| Device ID | K073670 |
| 510k Number | K073670 |
| Device Name: | KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | OREX COMPUTED RADIOGRAPHY LTD STAR YOKNEAM BLDG P.O. BOX 505 Yokneam, IL 20692 |
| Contact | Dan Laor |
| Correspondent | Dan Laor OREX COMPUTED RADIOGRAPHY LTD STAR YOKNEAM BLDG P.O. BOX 505 Yokneam, IL 20692 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-27 |
| Decision Date | 2008-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889971919878 | K073670 | 000 |
| 60889971024084 | K073670 | 000 |