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RadNet

Medical device makerAI. FDA files no records under this name; these are its 2 companies' records, each linked to the record.

  • Records across the group: 40, 3 entitiesAI
  • 510(k) clearances: 21
  • AI-enabled devices: 19

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, RadNet and its 2 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Jun 15, 2026Saige-DxK253825 · QDQ510(k) clearances
Jun 15, 2026Saige-DxK253825 · RadiologyAI-enabled devices
May 21, 2026BACK254131 · QIH510(k) clearances
May 21, 2026BACK254131 · RadiologyAI-enabled devices
Apr 29, 2026DeepHealth ProstateAIK253682 · QDQ510(k) clearances
Apr 29, 2026DeepHealth ProstateAIK253682 · RadiologyAI-enabled devices
Sep 25, 2025Brain WMHK251527 · QIH510(k) clearances
Sep 25, 2025Brain WMHK251527 · RadiologyAI-enabled devices
Aug 11, 2025Saige-DxK251873 · QDQ510(k) clearances
Aug 11, 2025Saige-DxK251873 · RadiologyAI-enabled devices
Jun 5, 2025TechLiveK243703 · LLZ510(k) clearances
Dec 19, 2024Saige-Density (2.5.0)K243705 · QIH510(k) clearances
Dec 19, 2024Saige-Dx (3.1.0)K243688 · QDQ510(k) clearances
Dec 19, 2024Saige-Density (2.5.0)K243705 · RadiologyAI-enabled devices
Dec 19, 2024Saige-Dx (3.1.0)K243688 · RadiologyAI-enabled devices
Nov 18, 2024Saige-DxK241747 · RadiologyAI-enabled devices

Subsidiaries and Divisions

2 firms in the RadNet group, most records first

Canada and Imports

Across the RadNet group, matched by company name
Active Health Canada device licences
1, as of Nov 10, 2026

Names and Identifiers

Appears as
Website
radnet.com

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

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.