510(k) Report

FDA applicant

Keystone X-Ray, Inc.

Neptune Township, NJ4 decisions1981–19930 recalls

FDA records 4 decisions for Keystone X-Ray, Inc. (Neptune Township, NJ) from 1981 to 1993: 4 510(k) clearances. Most are in product codes EAP (Unit, X-Ray, Intraoral) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). 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 Keystone X-Ray, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Keystone X-Ray, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Keystone X-Ray, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Keystone X-Ray, Inc.’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 “Keystone”

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