The following data is part of a premarket notification filed by 3m Medical Products Group with the FDA for 3m Digital Recording Automatic Film Handling Unit.
| Device ID | K912225 |
| 510k Number | K912225 |
| Device Name: | 3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT |
| Classification | Processor, Radiographic-film, Automatic |
| Applicant | 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 St. Paul, MN 55144 -1000 |
| Contact | John Gravelle |
| Correspondent | John Gravelle 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 St. Paul, MN 55144 -1000 |
| Product Code | IXW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-20 |
| Decision Date | 1991-07-22 |