510(k) Report

FDA applicant

Photodetection Systems, Inc.

Boxborough, MA1 decision2009–20090 recalls

FDA records 1 decision for Photodetection Systems, Inc. (Boxborough, MA) in 2009: 1 510(k) clearance. All are in product code KPS (System, Tomography, Computed, Emission). 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 Photodetection Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Photodetection Systems, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission1decision

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.

  • K091269NeuropetPhotodetection Systems, Inc. · 20091cites it

What has FDA decided for it lately?

  • K091269NeuropetPhotodetection Systems, Inc. · 2009

The one decision as Photodetection Systems, Inc. →