510(k) Report

FDA applicant

Ramsoft, Inc.

Toronto, On, CA6 decisions1994–20220 recalls

FDA records 6 decisions for Ramsoft, Inc. (Toronto, On, CA) from 1994 to 2022: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 11 predicates, 3 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 Ramsoft, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 12022: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ramsoft, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ramsoft, Inc.’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, Radiological5decisions
  • LMDSystem, Digital Image Communications, Radiological1decision

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 3 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.

  • K031562Ramsoft Pacs, Model 3.0Ramsoft, Inc. · 20035cite it
  • K222476OmegaAI Image ViewerRamsoft, Inc. · 20223cite it
  • K141881RapidresultsRamsoft, Inc. · 20142cite it
  • K982563Ultrapro Model 98Ramsoft, Inc. · 19981cites it

What has FDA decided for it lately?

  • K222476OmegaAI Image ViewerRamsoft, Inc. · 2022
  • K141881RapidresultsRamsoft, Inc. · 2014
  • K052460Powerserver, Powerreader, Gateway and PowercacheRamsoft, Inc. · 2005
  • K031562Ramsoft Pacs, Model 3.0Ramsoft, Inc. · 2003
  • K982563Ultrapro Model 98Ramsoft, Inc. · 1998
  • K942917Ultrapro WorkstationRamsoft, Inc. · 1994

All 6 as Ramsoft, Inc. →