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FDA 510(k)

MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190

K-Number: K052095 · 2005-11-03

ApplicantKonica Minolta Medical & Graphic, Inc.
Decision Date2005-11-03
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta Medical & Graphic, Inc.. It received FDA 510(k) clearance on 2005-11-03 under 510(k) number K052095. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190?

MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 is a medical device that received FDA 510(k) clearance on 2005-11-03. The listed applicant is Konica Minolta Medical & Graphic, Inc.. The 510(k) number is K052095.

When did MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 receive FDA 510(k) clearance?

MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 received FDA 510(k) clearance on 2005-11-03, under 510(k) number K052095.

Who is the listed applicant for MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190?

The FDA 510(k) record lists Konica Minolta Medical & Graphic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190?

The FDA product code for MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 is MQB.

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Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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