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FDA 510(k)

REGIUS MODEL 170 DIRECT DIGITIZER

K-Number: K051998 · 2005-11-03

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

Device Summary

REGIUS MODEL 170 DIRECT DIGITIZER 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 K051998. 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 REGIUS MODEL 170 DIRECT DIGITIZER?

REGIUS MODEL 170 DIRECT DIGITIZER 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 K051998.

When did REGIUS MODEL 170 DIRECT DIGITIZER receive FDA 510(k) clearance?

REGIUS MODEL 170 DIRECT DIGITIZER received FDA 510(k) clearance on 2005-11-03, under 510(k) number K051998.

Who is the listed applicant for REGIUS MODEL 170 DIRECT DIGITIZER?

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 REGIUS MODEL 170 DIRECT DIGITIZER?

The FDA product code for REGIUS MODEL 170 DIRECT DIGITIZER 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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