510(k) Report

FDA applicant

Sanko X-Ray Manufacturing Co., Ltd.

Virginia Beach, VA1 decision1998–19980 recalls

FDA records 1 decision for Sanko X-Ray Manufacturing Co., Ltd. (Virginia Beach, VA) in 1998: 1 510(k) clearance. All are in product code EHD (Unit, X-Ray, Extraoral With Timer). 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 Sanko X-Ray Manufacturing Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sanko X-Ray Manufacturing Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sanko X-Ray Manufacturing Co., Ltd.’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 “Sanko”

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