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FDA 510(k)

IMIX INSIGHT X-RAY SYSTEMS

K-Number: K073114 · 2008-01-17

ApplicantImix Adr Finland OY
Decision Date2008-01-17
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMIX INSIGHT X-RAY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Imix Adr Finland OY. It received FDA 510(k) clearance on 2008-01-17 under 510(k) number K073114. 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 IMIX INSIGHT X-RAY SYSTEMS?

IMIX INSIGHT X-RAY SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-01-17. The listed applicant is Imix Adr Finland OY. The 510(k) number is K073114.

When did IMIX INSIGHT X-RAY SYSTEMS receive FDA 510(k) clearance?

IMIX INSIGHT X-RAY SYSTEMS received FDA 510(k) clearance on 2008-01-17, under 510(k) number K073114.

Who is the listed applicant for IMIX INSIGHT X-RAY SYSTEMS?

The FDA 510(k) record lists Imix Adr Finland OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMIX INSIGHT X-RAY SYSTEMS?

The FDA product code for IMIX INSIGHT X-RAY SYSTEMS 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 Imix Adr Finland OY 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.

K113855PANORAD, PANORAD SLK101435IMIX PANORAD AND SOMARADK072867IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K

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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