510(k) Report

FDA applicant

Clearview Diagnostics, Inc.

Piscataway, NJ2 decisions2014–20161 recall

FDA records 2 decisions for Clearview Diagnostics, Inc. (Piscataway, NJ) from 2014 to 2016: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 Clearview Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12016: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2014high 1 (2019) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Clearview Diagnostics, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Clearview Diagnostics, 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 “Clearview”

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