510(k) Report

FDA applicant

Leiker Regulatory & Quality Consulting

Dublin, CA1 decision2012–20120 recalls

FDA records 1 decision for Leiker Regulatory & Quality Consulting (Dublin, CA) in 2012: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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 Leiker Regulatory & Quality Consulting’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Leiker Regulatory & Quality Consulting by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

What has FDA decided for it lately?

  • K112539Chison Digital Ultrasound System, Convex Probe, Linear Probe, Transvaginal Micro-Convex Probe, Transrectal…Leiker Regulatory & Quality Consulting · 2012

The one decision as Leiker Regulatory & Quality Consulting →