510(k) Report

FDA applicant

Simpleware, Ltd.

Exeter, GB1 decision2015–20152 recalls

FDA records 1 decision for Simpleware, Ltd. (Exeter, GB) in 2015: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are 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 Simpleware, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2021

2021: 2
2015high 2 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Simpleware, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Simpleware, Ltd.’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

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

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.

  • K142779Scanip; Scanip: Medical Edition; Scanip: MedSimpleware, Ltd. · 20151cites it

What has FDA decided for it lately?

  • K142779Scanip; Scanip: Medical Edition; Scanip: MedSimpleware, Ltd. · 20152 recalls

The one decision as Simpleware, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K142779Simpleware ScanIP medical software. For transfer of imaging information from a medical…Jun 4, 2021Class II
  • K142779Simpleware ScanIP software. For transfer of imaging information from a medical scanner…Jun 4, 2021Class II