510(k) Report

FDA applicant

Mckesson Medical Imaging Company

Richmond, B.C., CA3 decisions2005–201515 recalls

FDA records 3 decisions for Mckesson Medical Imaging Company (Richmond, B.C., CA) from 2005 to 2015: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 6 predicates, 1 of them its own earlier devices. 15 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 Mckesson Medical Imaging Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2010: 12011: 12012: 12013: 32014: 32016: 32020: 12023: 12025: 1
2007high 3 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Mckesson”

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