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FDA 510(k)

DX-D IMAGING PACKAGE

K-Number: K121095 · 2012-08-16

ApplicantAgfa Healthcare N.V.
Decision Date2012-08-16
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DX-D IMAGING PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2012-08-16 under 510(k) number K121095. 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 DX-D IMAGING PACKAGE?

DX-D IMAGING PACKAGE is a medical device that received FDA 510(k) clearance on 2012-08-16. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K121095.

When did DX-D IMAGING PACKAGE receive FDA 510(k) clearance?

DX-D IMAGING PACKAGE received FDA 510(k) clearance on 2012-08-16, under 510(k) number K121095.

Who is the listed applicant for DX-D IMAGING PACKAGE?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DX-D IMAGING PACKAGE?

The FDA product code for DX-D IMAGING PACKAGE is MQB.

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Other records listing Agfa Healthcare N.V. 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.

K252199AGFA HealthCare Enterprise ImagingK180589DR 800 with MUSICA DynamicK172784DX-D Imaging PackageK170434Enterprise Imaging XERO Viewer 8.1K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)K161061IMPAX Volume Viewing 4.0

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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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