The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Konicaminolta Di-x1.
| Device ID | K182431 |
| 510k Number | K182431 |
| Device Name: | Konicaminolta DI-X1 |
| Classification | System, Image Processing, Radiological |
| Applicant | Konica Minolta, Inc. 1 Sakura-machi Hino-shi, JP 191-8511 |
| Contact | Tsutomu Fukui |
| Correspondent | Russell D. Munves Storch Amini PC 140 East 45th Street 25th Floor Newyork, NY 10017 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-06 |
| Decision Date | 2018-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141947788 | K182431 | 000 |
| 04560141947771 | K182431 | 000 |