The following data is part of a premarket notification filed by Codonics, Inc. with the FDA for Codonics Horizon Xl Digital Direct Long Film Imager; Codonics Horizon Xl-x Long Film Imager.
| Device ID | K060440 |
| 510k Number | K060440 |
| Device Name: | CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | CODONICS, INC. 17991 ENGLEWOOD DR. Middleburg Heights, OH 44130 |
| Contact | Alan Desantis |
| Correspondent | Alan Desantis CODONICS, INC. 17991 ENGLEWOOD DR. Middleburg Heights, OH 44130 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-21 |
| Decision Date | 2006-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814905020120 | K060440 | 000 |
| 00814905020045 | K060440 | 000 |