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FDA 510(k)

QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI

K-Number: K080905 · 2008-07-16

ApplicantQuantum Medical Imaging, LLC
Decision Date2008-07-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI 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 2008-07-16 under 510(k) number K080905. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI?

QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI is a medical device that received FDA 510(k) clearance on 2008-07-16. The listed applicant is Quantum Medical Imaging, LLC. The 510(k) number is K080905.

When did QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI receive FDA 510(k) clearance?

QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI received FDA 510(k) clearance on 2008-07-16, under 510(k) number K080905.

Who is the listed applicant for QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI?

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/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI?

The FDA product code for QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI is LLZ.

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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 SYSTEMK072010QUANTUM DIREX SYSTEMK023008UNIVERSAL SYSTEM, MODEL QV-800K011486Q-RAD RADIOGRAPHIC SYSTEM

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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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