The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Ds Cassette.
| Device ID | K053173 |
| 510k Number | K053173 |
| Device Name: | DS CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 319 AKENO, OBATA-CHO WATARAI-GUN Mie-ken, JP 519-05 |
| Contact | Shinichi Yamanaka |
| Correspondent | Shinichi Yamanaka KONICA MINOLTA MEDICAL & GRAPHIC, INC. 319 AKENO, OBATA-CHO WATARAI-GUN Mie-ken, JP 519-05 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2005-12-15 |
| Summary: | summary |