510(k) Report

FDA applicant

Quantum Medical Imaging, LLC

Ronkonkoma, NY5 decisions2001–20080 recalls

FDA records 5 decisions for Quantum Medical Imaging, LLC (Ronkonkoma, NY) from 2001 to 2008: 5 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and LLZ (System, Image Processing, Radiological). Its devices cite 11 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Quantum Medical Imaging, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007: 12008: 2
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Quantum Medical Imaging, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Quantum Medical Imaging, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KPRSystem, X-Ray, Stationary4decisions
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 11 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011486Q-Rad Radiographic SystemQuantum Medical Imaging, LLC · 20015cite it
  • K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 20081cites it
  • K023008Universal System, Model QV-800Quantum Medical Imaging, LLC · 20021cites it
  • K072010Quantum Direx SystemQuantum Medical Imaging, LLC · 20071cites it

What has FDA decided for it lately?

  • K083181QV-9000 Universal SystemQuantum Medical Imaging, LLC · 2008
  • K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008
  • K072010Quantum Direx SystemQuantum Medical Imaging, LLC · 2007
  • K023008Universal System, Model QV-800Quantum Medical Imaging, LLC · 2002
  • K011486Q-Rad Radiographic SystemQuantum Medical Imaging, LLC · 2001

All 5 as Quantum Medical Imaging, LLC →

Other applicant names beginning “Quantum”

FDA records each applicant name separately; these may or may not be the same firm.

Quantum Orthopedics, Inc. 6Quantum Medical Systems, Inc. 5Quantum Bioengineering, Ltd. 4Quantum Co., Ltd. 3Quantum Medical Concepts, LLC 2Quantum Instruments Corp. 2Quantum Surgical Sas 2Quantum Devices, Inc. 2Quantum Skincare, Inc. 1Quantum Intl. 1Quantum Medical Imaging Divison of Carestream 1Quantum Life Systems, Inc. 1