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 |