FDA applicant

Perspectum Diagnostics, Ltd.

Oxford, GB3 decisions2017–20190 recalls

FDA records 3 decisions for Perspectum Diagnostics, Ltd. (Oxford, GB) from 2017 to 2019: 3 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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 Perspectum Diagnostics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2017high 2 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Perspectum Diagnostics, Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Perspectum Diagnostics, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Perspectum”

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

Perspectum, Ltd. 8

Perspectum Diagnostics, Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Perspectum”