The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Dr-id 1200sdk System.
| Device ID | K200668 |
| 510k Number | K200668 |
| Device Name: | DR-ID 1200SDK System |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Kamila Sak FUJIFILM Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-13 |
| Decision Date | 2020-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410436723 | K200668 | 000 |
| 04547410436716 | K200668 | 000 |
| 04547410436709 | K200668 | 000 |
| 04547410436693 | K200668 | 000 |
| 04547410436686 | K200668 | 000 |