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 |