The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Aerodr X70.
| Device ID | K121109 |
| 510k Number | K121109 |
| Device Name: | AERODR X70 |
| Classification | System, X-ray, Stationary |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. NO. 1 SAKURA-MACHI, HINO-SHI Tokyo, JP 191-8511 |
| Contact | Shigeyuki Kojima |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-04-12 |
| Decision Date | 2012-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141946262 | K121109 | 000 |
| 04560141946248 | K121109 | 000 |
| 04560141946231 | K121109 | 000 |
| 04560141935372 | K121109 | 000 |