Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GE HealthCareLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Bay Labs, Inc. with 2 AI-enabled devices and 1 510(k) clearance. The most recent is a 510(k) clearance dated Feb 7, 2020: Caption Guidance.
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.
| Feb 7, 2020 | Caption GuidanceDEN190040 · QJU | 510(k) clearances |
| Feb 7, 2020 | Caption GuidanceDEN190040 · Radiology | AI-enabled devices |
| Jun 14, 2018 | EchoMD Automated Ejection Fraction SoftwareK173780 · LLZ | 510(k) clearances |
| Jun 14, 2018 | EchoMD Automated Ejection Fraction SoftwareK173780 · Radiology | AI-enabled devices |
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
