ImagePilot

System, Image Processing, Radiological

Konica Minolta, Inc.

The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Imagepilot.

Pre-market Notification Details

Device IDK210066
510k NumberK210066
Device Name:ImagePilot
ClassificationSystem, Image Processing, Radiological
Applicant Konica Minolta, Inc. 1 Sakura-machi Hino-shi,  JP 191-8511
ContactTsutomu Fukui
CorrespondentJan Maniscalco
Konica Minolta Healthcare Americas, Inc. 411 Newark-Pompton Turnpike Wayne,  NJ  27529
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-11
Decision Date2021-05-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560141949492 K210066 000
04560141950382 K210066 000
04560141950399 K210066 000

Trademark Results [ImagePilot]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMAGEPILOT
IMAGEPILOT
77281396 3640432 Live/Registered
Konica Minolta, Inc.
2007-09-17

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