QUANTUM DIREX SYSTEM— 510(k) K072010

Name: FDA 510(k) clearance K072010
Creator: U.S. Food and Drug Administration
Published: 2007-08-07

Substantially Equivalent

Quantum Medical Imaging, LLC

FDA 510(k) clearance K072010 for QUANTUM DIREX SYSTEM, Substantially Equivalent on 2007-08-07. Applicant: Quantum Medical Imaging, LLC. Device class: 2.

Clearance details

Applicant: Quantum Medical Imaging, LLC
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2007-07-23
Decision date: 2007-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, US

Download summary PDF View on FDA.gov ↗

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K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
K260481 — GC85A2026-08-27
K260482 — DRE Duo2026-06-15
K253446 — AeroDR TX c022026-04-10

More clearances from Quantum Medical Imaging, LLC

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K083181 — QV-9000 UNIVERSAL SYSTEM2008-11-26
K080905 — QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI2008-07-16
K023008 — UNIVERSAL SYSTEM, MODEL QV-8002002-11-13
K011486 — Q-RAD RADIOGRAPHIC SYSTEM2001-06-20

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.