The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Imagepilot.
| Device ID | K210066 | 
| 510k Number | K210066 | 
| Device Name: | ImagePilot | 
| Classification | System, Image Processing, Radiological | 
| Applicant | Konica Minolta, Inc. 1 Sakura-machi Hino-shi, JP 191-8511 | 
| Contact | Tsutomu Fukui | 
| Correspondent | Jan Maniscalco Konica Minolta Healthcare Americas, Inc. 411 Newark-Pompton Turnpike Wayne, NJ 27529 | 
| Product Code | LLZ | 
| CFR Regulation Number | 892.2050 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Special | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2021-01-11 | 
| Decision Date | 2021-05-06 | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 04560141949492 | K210066 | 000 | 
| 04560141950382 | K210066 | 000 | 
| 04560141950399 | K210066 | 000 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  IMAGEPILOT  77281396  3640432 Live/Registered | Konica Minolta, Inc. 2007-09-17 |