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FDA 510(k)

COMPUTED RADDIOGRAPHY SCANNER

K-Number: K102619 · 2011-05-13

Applicant3Disc Americas
Decision Date2011-05-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTED RADDIOGRAPHY SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is 3Disc Americas. It received FDA 510(k) clearance on 2011-05-13 under 510(k) number K102619. 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 COMPUTED RADDIOGRAPHY SCANNER?

COMPUTED RADDIOGRAPHY SCANNER is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is 3Disc Americas. The 510(k) number is K102619.

When did COMPUTED RADDIOGRAPHY SCANNER receive FDA 510(k) clearance?

COMPUTED RADDIOGRAPHY SCANNER received FDA 510(k) clearance on 2011-05-13, under 510(k) number K102619.

Who is the listed applicant for COMPUTED RADDIOGRAPHY SCANNER?

The FDA 510(k) record lists 3Disc Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPUTED RADDIOGRAPHY SCANNER?

The FDA product code for COMPUTED RADDIOGRAPHY SCANNER is MQB.

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Other records listing 3Disc Americas 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.

K131442FIRECR DENTALIMAGING SYSTEM

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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