FDA applicant

Jazz Imaging

San Jose, CA2 decisions2017–20240 recalls

FDA records 2 decisions for Jazz Imaging (San Jose, CA) from 2017 to 2024: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Jazz Imaging, LLC”.

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 Jazz Imaging’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Jazz Imaging by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Jazz”

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

Jazz Imaging, LLC Dba Jazz Imaging 1

Jazz Imaging

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Jazz”