The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Aerosync For Aerodr System.
| Device ID | K120477 |
| 510k Number | K120477 |
| Device Name: | AEROSYNC FOR AERODR SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017 |
| Contact | Ressell Munves |
| Correspondent | Ressell Munves KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER 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 | 2012-02-16 |
| Decision Date | 2012-04-09 |
| Summary: | summary |