FDA applicant

Electro-Diagnostic Imaging, Inc.

Los Altos, CA2 decisions1999–20010 recalls

FDA records 2 decisions for Electro-Diagnostic Imaging, Inc. (Los Altos, CA) from 1999 to 2001: 2 510(k) clearances. All are in product code HLX (Photostimulator, Ac-Powered). Its devices cite 3 predicates, 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, ophthalmic panel, where it files most

How often FDA has decided Electro-Diagnostic Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Electro-Diagnostic Imaging, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Electro-Diagnostic Imaging, 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 “Electro-Diagnostic”

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

Electro-Nucleonics Laboratories, Inc. 41 Electro-Catheter Corp. 35 Electro-Biology, Inc. 28 Electro Medical Systems SA 11 Electro-Nucleonics, Inc. 9 Electro Therapeutic Devices, Inc. 8 Electro Med Supply, Inc. 8 Electro-Med Health Industries, Inc. 6 Electro-Diagnostic Instruments 4 Electro Medical Systems (Ems Sa) 3 Electro Fiberoptics Corp. 3 Electro-Cap Intl., Inc. 3

Electro-Diagnostic Imaging, Inc.

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 “Electro-Diagnostic”