FDA applicant

Quantum Medical Imaging Divison of Carestream

Ronkonkoma, NY1 decision2015–20150 recalls

FDA records 1 decision for Quantum Medical Imaging Divison of Carestream (Ronkonkoma, NY) in 2015: 1 510(k) clearance. All are in product code KPR (System, X-Ray, Stationary). Its devices cite 1 predicate, 0 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 Divison of Carestream’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Quantum Medical Imaging Divison of Carestream by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Quantum”

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

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

Quantum Medical Imaging Divison of Carestream

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Quantum”