510(k) Report

FDA applicant

Konica Minolta Medical & Graphic, Inc.

New York, NY27 decisions2002–20133 recalls

FDA records 27 decisions for Konica Minolta Medical & Graphic, Inc. (New York, NY) from 2002 to 2013: 27 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LMC (Camera, Multi Format, Radiological). Its devices cite 29 predicates, 17 of them its own earlier devices. 3 recalls are 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 Konica Minolta Medical & Graphic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 22008: 12009: 12010: 12011: 32012: 62013: 1
2007high 6 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Konica Minolta Medical & Graphic, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Konica Minolta Medical & Graphic, Inc.’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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Other applicant names beginning “Konica”

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