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FDA 510(k)

DX-D 600

K-Number: K112670 · 2011-10-27

ApplicantAgfa Healthcare N.V.
Decision Date2011-10-27
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DX-D 600 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 2011-10-27 under 510(k) number K112670. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DX-D 600?

DX-D 600 is a medical device that received FDA 510(k) clearance on 2011-10-27. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K112670.

When did DX-D 600 receive FDA 510(k) clearance?

DX-D 600 received FDA 510(k) clearance on 2011-10-27, under 510(k) number K112670.

Who is the listed applicant for DX-D 600?

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 600?

The FDA product code for DX-D 600 is KPR.

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: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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