The following data is part of a premarket notification filed by Orion Corp. with the FDA for Resubmitted Scanora.
| Device ID | K884650 |
| 510k Number | K884650 |
| Device Name: | RESUBMITTED SCANORA |
| Classification | System, X-ray, Tomographic |
| Applicant | ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Contact | Ensio Koskennurmi |
| Correspondent | Ensio Koskennurmi ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1989-03-16 |