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FDA 510(k)

GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS

K-Number: K132294 · 2013-11-12

ApplicantRadiology Solutions, LLC
Decision Date2013-11-12
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Radiology Solutions, LLC. It received FDA 510(k) clearance on 2013-11-12 under 510(k) number K132294. 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 GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS?

GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS is a medical device that received FDA 510(k) clearance on 2013-11-12. The listed applicant is Radiology Solutions, LLC. The 510(k) number is K132294.

When did GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS receive FDA 510(k) clearance?

GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS received FDA 510(k) clearance on 2013-11-12, under 510(k) number K132294.

Who is the listed applicant for GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS?

The FDA 510(k) record lists Radiology Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS?

The FDA product code for GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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