Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Intelerad Medical Systems with 5 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Apr 2, 2020: IntelePACS.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 2, 2020 | IntelePACSK192176 · LLZ | 510(k) clearances |
| May 27, 2015 | IntelePACSK150707 · LLZ | 510(k) clearances |
| Jul 3, 2014 | IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sClass II · In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file | Device recalls |
| Jun 23, 2009 | INTELEPACS, MODEL VERSION 3.X.XK083520 · LLZ | 510(k) clearances |
| Jan 24, 2007 | INTELEPACSK070080 · LLZ | 510(k) clearances |
| Oct 16, 2003 | INTELEPACSK032533 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
