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FDA 510(k)

DX-D FULL LEG FULL SPINE

K-Number: K122119 · 2012-09-13

ApplicantAfga Healthcare N.V.
Decision Date2012-09-13
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DX-D FULL LEG FULL SPINE is the device name listed in this FDA 510(k) record. The listed applicant is Afga Healthcare N.V.. It received FDA 510(k) clearance on 2012-09-13 under 510(k) number K122119. 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 FULL LEG FULL SPINE?

DX-D FULL LEG FULL SPINE is a medical device that received FDA 510(k) clearance on 2012-09-13. The listed applicant is Afga Healthcare N.V.. The 510(k) number is K122119.

When did DX-D FULL LEG FULL SPINE receive FDA 510(k) clearance?

DX-D FULL LEG FULL SPINE received FDA 510(k) clearance on 2012-09-13, under 510(k) number K122119.

Who is the listed applicant for DX-D FULL LEG FULL SPINE?

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

What is the FDA product code for DX-D FULL LEG FULL SPINE?

The FDA product code for DX-D FULL LEG FULL SPINE is KPR.

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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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