FDA applicant

Sterling Diagnostic Imaging, Inc.

Greenville, SC7 decisions1996–19980 recalls

FDA records 7 decisions for Sterling Diagnostic Imaging, Inc. (Greenville, SC) from 1996 to 1998: 7 510(k) clearances. Most are in product codes LMC (Camera, Multi Format, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 7 predicates, 2 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 Sterling Diagnostic Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterling Diagnostic Imaging, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sterling 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 “Sterling”

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

Sterling Diagnostics, Inc. 41 Sterling Medivations, Inc. 27 Sterling Biochemical, Inc. 15 Sterling Drug, Inc. 9 Sterling Medical Devices, Inc. 2 Sterling U.S.A., Inc. 1 Sterling Medical, Inc. 1 Sterling Multi-Products, Inc. 1

Sterling 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 “Sterling”