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FDA 510(k)

DIGITAL RADIOGRAPHY

K-Number: K112309 · 2011-09-02

ApplicantCanon Inc. -Medical Equipment Group
Decision Date2011-09-02
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL RADIOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Canon Inc. -Medical Equipment Group. It received FDA 510(k) clearance on 2011-09-02 under 510(k) number K112309. 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 DIGITAL RADIOGRAPHY?

DIGITAL RADIOGRAPHY is a medical device that received FDA 510(k) clearance on 2011-09-02. The listed applicant is Canon Inc. -Medical Equipment Group. The 510(k) number is K112309.

When did DIGITAL RADIOGRAPHY receive FDA 510(k) clearance?

DIGITAL RADIOGRAPHY received FDA 510(k) clearance on 2011-09-02, under 510(k) number K112309.

Who is the listed applicant for DIGITAL RADIOGRAPHY?

The FDA 510(k) record lists Canon Inc. -Medical Equipment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL RADIOGRAPHY?

The FDA product code for DIGITAL RADIOGRAPHY is MQB.

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Other records listing Canon Inc. -Medical Equipment Group as applicant

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.

K173689Ophthalmic Software Platform RXK162909CSX-30 Flat Panel DetectorK123208DIGITAL RETINAL CAMERAK121303MOBILE C-ARMK111824FLAT PANEL DETECTORK111710FULL AUTO TONOMETER MODEL TX-20

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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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