FDA applicant

Jazz Imaging, LLC Dba Jazz Imaging

San Jose, CA1 decision2021–20210 recalls

FDA records 1 decision for Jazz Imaging, LLC Dba Jazz Imaging (San Jose, CA) in 2021: 1 510(k) clearance. All are in product code MUH (System, X-Ray, Extraoral Source, Digital). 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, dental panel, where it files most

How often FDA has decided Jazz Imaging, LLC Dba Jazz Imaging’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Jazz Imaging, LLC Dba Jazz Imaging by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jazz Imaging, LLC Dba 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 2

Jazz Imaging, LLC Dba Jazz Imaging

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Jazz”