FDA applicant

Sony Medical Electronics Co.

North Attleboro, MA8 decisions1988–19980 recalls

FDA records 8 decisions for Sony Medical Electronics Co. (North Attleboro, MA) from 1988 to 1998: 8 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and IZI (System, X-Ray, Angiographic). 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, radiology panel, where it files most

How often FDA has decided Sony Medical Electronics Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sony Medical Electronics Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sony Medical Electronics Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sony Medical Electronics Co.’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 “Sony”

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

Sony Electronics, Inc. 8 Sony Medical Systems 6 Sony Corp. of America 2 Sony Corporation 1

Sony Medical Electronics Co.

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 “Sony”