The following data is part of a premarket notification filed by Imation Corp. with the FDA for Imation Se-196 Laser Imager.
| Device ID | K972163 |
| 510k Number | K972163 |
| Device Name: | IMATION SE-196 LASER IMAGER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | IMATION CORP. 1 IMATION PLACE Oakdale, MN 55128 |
| Contact | Stephen G Slavens |
| Correspondent | Stephen G Slavens IMATION CORP. 1 IMATION PLACE Oakdale, MN 55128 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-09-05 |
| Summary: | summary |