The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Modification To Lr 5200 Film Recorder.
| Device ID | K012010 |
| 510k Number | K012010 |
| Device Name: | MODIFICATION TO LR 5200 FILM RECORDER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | AGFA CORP. 12300 TWINBROOK PKWY,STE 625 Rockville, MD 20852 |
| Contact | T.whit Athey |
| Correspondent | T.whit Athey AGFA CORP. 12300 TWINBROOK PKWY,STE 625 Rockville, MD 20852 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-27 |
| Decision Date | 2001-09-20 |
| Summary: | summary |