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FDA 510(k)

KONICA DIRECT DIGITIZER REGIUS MODEL 350

K-Number: K013054 · 2002-03-01

ApplicantKonica Minolta Medical & Graphic, Inc.
Decision Date2002-03-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KONICA DIRECT DIGITIZER REGIUS MODEL 350 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 2002-03-01 under 510(k) number K013054. 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 KONICA DIRECT DIGITIZER REGIUS MODEL 350?

KONICA DIRECT DIGITIZER REGIUS MODEL 350 is a medical device that received FDA 510(k) clearance on 2002-03-01. The listed applicant is Konica Minolta Medical & Graphic, Inc.. The 510(k) number is K013054.

When did KONICA DIRECT DIGITIZER REGIUS MODEL 350 receive FDA 510(k) clearance?

KONICA DIRECT DIGITIZER REGIUS MODEL 350 received FDA 510(k) clearance on 2002-03-01, under 510(k) number K013054.

Who is the listed applicant for KONICA DIRECT DIGITIZER REGIUS MODEL 350?

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 KONICA DIRECT DIGITIZER REGIUS MODEL 350?

The FDA product code for KONICA DIRECT DIGITIZER REGIUS MODEL 350 is MQB.

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Other records listing Konica Minolta Medical & Graphic, Inc. as applicant

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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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