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FDA 510(k)

DRX-EVOLUTION, MODEL VX3733-SYS

K-Number: K091889 · 2009-07-20

ApplicantCarestream Health, Inc.
Decision Date2009-07-20
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRX-EVOLUTION, MODEL VX3733-SYS is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2009-07-20 under 510(k) number K091889. 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 DRX-EVOLUTION, MODEL VX3733-SYS?

DRX-EVOLUTION, MODEL VX3733-SYS is a medical device that received FDA 510(k) clearance on 2009-07-20. The listed applicant is Carestream Health, Inc.. The 510(k) number is K091889.

When did DRX-EVOLUTION, MODEL VX3733-SYS receive FDA 510(k) clearance?

DRX-EVOLUTION, MODEL VX3733-SYS received FDA 510(k) clearance on 2009-07-20, under 510(k) number K091889.

Who is the listed applicant for DRX-EVOLUTION, MODEL VX3733-SYS?

The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRX-EVOLUTION, MODEL VX3733-SYS?

The FDA product code for DRX-EVOLUTION, MODEL VX3733-SYS is KPR.

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Other records listing Carestream Health, Inc. 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.

K251168Image SuiteK241505DRX-Revolution Mobile X-ray SystemK233381DRX-Evolution Plus SystemK223842DRX - CompassK213307Eclipse II with Smart Noise CancellationK202441Eclipse II with Smart Noise Cancellation

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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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