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FDA 510(k)

UNIVERSAL SYSTEM, MODEL QV-800

K-Number: K023008 · 2002-11-13

ApplicantQuantum Medical Imaging, LLC
Decision Date2002-11-13
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL SYSTEM, MODEL QV-800 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 2002-11-13 under 510(k) number K023008. 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 UNIVERSAL SYSTEM, MODEL QV-800?

UNIVERSAL SYSTEM, MODEL QV-800 is a medical device that received FDA 510(k) clearance on 2002-11-13. The listed applicant is Quantum Medical Imaging, LLC. The 510(k) number is K023008.

When did UNIVERSAL SYSTEM, MODEL QV-800 receive FDA 510(k) clearance?

UNIVERSAL SYSTEM, MODEL QV-800 received FDA 510(k) clearance on 2002-11-13, under 510(k) number K023008.

Who is the listed applicant for UNIVERSAL SYSTEM, MODEL QV-800?

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 UNIVERSAL SYSTEM, MODEL QV-800?

The FDA product code for UNIVERSAL SYSTEM, MODEL QV-800 is KPR.

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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 SYSTEMK080905QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDIK072010QUANTUM DIREX SYSTEMK011486Q-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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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