The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Aerodr System 2.
| Device ID | K141271 |
| 510k Number | K141271 |
| Device Name: | AERODR SYSTEM 2 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KONICA MINOLTA, INC. 140 EAST 45TH STREET 25TH FLOOR New York, NY 10017 |
| Contact | Russell D Munves |
| Correspondent | Russell D Munves KONICA MINOLTA, INC. 140 EAST 45TH STREET 25TH FLOOR New York, NY 10017 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-15 |
| Decision Date | 2014-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141944329 | K141271 | 000 |
| 04560141941298 | K141271 | 000 |
| 04560141940659 | K141271 | 000 |