510(k) Report

FDA applicant

Olympus America Inc. / Scientific Equipment Group

Center Valley, PA1 decision2012–20120 recalls

FDA records 1 decision for Olympus America Inc. / Scientific Equipment Group (Center Valley, PA) in 2012: 1 510(k) clearance. All are in product code OEO (Automated Digital Image Manual Interpretation…). 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, hematology panel, where it files most

How often FDA has decided Olympus America Inc. / Scientific Equipment Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Olympus America Inc. / Scientific Equipment Group by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OEOAutomated Digital Image Manual Interpretation Microscope1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K111914Virtual Slide System, Olympus VS800 SystemOlympus America Inc. / Scientific Equipment Group · 20121cites it

What has FDA decided for it lately?

  • K111914Virtual Slide System, Olympus VS800 SystemOlympus America Inc. / Scientific Equipment Group · 2012

The one decision as Olympus America Inc. / Scientific Equipment Group →

Other applicant names beginning “Olympus”

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

Olympus Medical Systems Corp. 190Olympus America, Inc. 149Olympus Corp. 149Olympus Optical Co., Ltd. 48Olympus Winter & Ibe GmbH 43Olympus Surgical Technologies America 14Olympus Diagnostica GmbH 4Olympus Life Science Research Europa GmbH (Europa) 3Olympus Terumo Biomaterials Corporation 3Olympus Life & Material Science Europa GmbH (Irish 3Olympus Corp of America 2Olympus Opto-Electronics Co., Ltd. 2