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)

QUANTUM DIREX SYSTEM

K-Number: K072010 · 2007-08-07

ApplicantQuantum Medical Imaging, LLC
Decision Date2007-08-07
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QUANTUM DIREX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Medical Imaging, LLC. It received FDA 510(k) clearance on 2007-08-07 under 510(k) number K072010. 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 QUANTUM DIREX SYSTEM?

QUANTUM DIREX SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-07. The listed applicant is Quantum Medical Imaging, LLC. The 510(k) number is K072010.

When did QUANTUM DIREX SYSTEM receive FDA 510(k) clearance?

QUANTUM DIREX SYSTEM received FDA 510(k) clearance on 2007-08-07, under 510(k) number K072010.

Who is the listed applicant for QUANTUM DIREX SYSTEM?

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

What is the FDA product code for QUANTUM DIREX SYSTEM?

The FDA product code for QUANTUM DIREX 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 Quantum Medical Imaging, LLC 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.

K083181QV-9000 UNIVERSAL SYSTEMK080905QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDIK023008UNIVERSAL SYSTEM, MODEL QV-800K011486Q-RAD RADIOGRAPHIC SYSTEM

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.

↑