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FDA 510(k)

MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM

K-Number: K052541 · 2005-11-03

ApplicantAvant Medical Systems
Decision Date2005-11-03
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Avant Medical Systems. It received FDA 510(k) clearance on 2005-11-03 under 510(k) number K052541. 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 MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM?

MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-11-03. The listed applicant is Avant Medical Systems. The 510(k) number is K052541.

When did MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM receive FDA 510(k) clearance?

MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM received FDA 510(k) clearance on 2005-11-03, under 510(k) number K052541.

Who is the listed applicant for MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM?

The FDA 510(k) record lists Avant Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM?

The FDA product code for MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM 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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