The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Aerodr System 2.
| Device ID | K151465 |
| 510k Number | K151465 |
| Device Name: | AeroDR SYSTEM 2 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KONICA MINOLTA, INC. 1 SAKURA-MACHI Hino-shi, JP 191-8511 |
| Contact | Shigeyuki Kojima |
| Correspondent | Russell D Munves STORCH AMINI & MUNVES PC 140 EAST 45TH STREET, 25TH FLOOR New York, NY 10017 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2015-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141945166 | K151465 | 000 |
| 04560141944572 | K151465 | 000 |
| 04560141944565 | K151465 | 000 |
| 04560141941694 | K151465 | 000 |