510(k) Report

FDA applicant

Philips Image Guided Therapy Corporation (Formerly Intact)

Plymouth1 decision2020–20201 recall

FDA records 1 decision for Philips Image Guided Therapy Corporation (Formerly Intact) (Plymouth) in 2020: 1 original PMA approval. All are in product code QCT (Scaffold, Dissection Repair). 1 recall is linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Philips Image Guided Therapy Corporation (Formerly Intact)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1, 1 Class I
2020high 1 (2025) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Philips Image Guided Therapy Corporation (Formerly Intact) by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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