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FDA 510(k)

REGUIS SIGMA

K-Number: K103703 · 2011-06-02

ApplicantKonica Minolta Medical & Graphic, Inc.
Decision Date2011-06-02
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REGUIS SIGMA 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 2011-06-02 under 510(k) number K103703. 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 REGUIS SIGMA?

REGUIS SIGMA is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Konica Minolta Medical & Graphic, Inc.. The 510(k) number is K103703.

When did REGUIS SIGMA receive FDA 510(k) clearance?

REGUIS SIGMA received FDA 510(k) clearance on 2011-06-02, under 510(k) number K103703.

Who is the listed applicant for REGUIS SIGMA?

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 REGUIS SIGMA?

The FDA product code for REGUIS SIGMA is MQB.

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

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K130936AERODR SYSTEM WITH P-31K123499AEROPILOTK120752AERODR STITCHING SYSTEMK121109AERODR X70K120477AEROSYNC FOR AERODR SYSTEMK120131REGIUS SIGMA2

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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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