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FDA 510(k)

RADVISION ET DIAGNOSTIC X-RAY SYSTEM

K-Number: K082064 · 2008-08-22

ApplicantAlmana Medical Imaging
Decision Date2008-08-22
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADVISION ET DIAGNOSTIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Almana Medical Imaging. It received FDA 510(k) clearance on 2008-08-22 under 510(k) number K082064. 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 RADVISION ET DIAGNOSTIC X-RAY SYSTEM?

RADVISION ET DIAGNOSTIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-22. The listed applicant is Almana Medical Imaging. The 510(k) number is K082064.

When did RADVISION ET DIAGNOSTIC X-RAY SYSTEM receive FDA 510(k) clearance?

RADVISION ET DIAGNOSTIC X-RAY SYSTEM received FDA 510(k) clearance on 2008-08-22, under 510(k) number K082064.

Who is the listed applicant for RADVISION ET DIAGNOSTIC X-RAY SYSTEM?

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

What is the FDA product code for RADVISION ET DIAGNOSTIC X-RAY SYSTEM?

The FDA product code for RADVISION ET DIAGNOSTIC X-RAY SYSTEM is KPR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Almana Medical Imaging 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.

K100001MOBIVISIONK080847RFVISION, MODEL 9.9DK080614DR VISION NEO, DR VISION DOUK072659RAD VISION, MODELS E AND EU

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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