Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PANORAD, PANORAD SL

K-Number: K113855 · 2012-01-25

ApplicantImix Adr Finland OY
Decision Date2012-01-25
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PANORAD, PANORAD SL 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 2012-01-25 under 510(k) number K113855. 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 PANORAD, PANORAD SL?

PANORAD, PANORAD SL is a medical device that received FDA 510(k) clearance on 2012-01-25. The listed applicant is Imix Adr Finland OY. The 510(k) number is K113855.

When did PANORAD, PANORAD SL receive FDA 510(k) clearance?

PANORAD, PANORAD SL received FDA 510(k) clearance on 2012-01-25, under 510(k) number K113855.

Who is the listed applicant for PANORAD, PANORAD SL?

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 PANORAD, PANORAD SL?

The FDA product code for PANORAD, PANORAD SL 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.

K101435IMIX PANORAD AND SOMARADK073114IMIX INSIGHT X-RAY SYSTEMSK072867IMIX 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.

↑