Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of NanoxLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Zebra Medical Vision with 9 510(k) clearances and 9 AI-enabled devices. The most recent is a 510(k) clearance dated Dec 15, 2021: HealthPPT.
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.
| Dec 15, 2021 | HealthPPTK211803 · QFM | 510(k) clearances |
| Dec 15, 2021 | HealthPPTK211803 · Radiology | AI-enabled devices |
| Sep 15, 2021 | HealthCCSngK210085 · JAK | 510(k) clearances |
| Sep 15, 2021 | HealthCCSngK210085 · Radiology | AI-enabled devices |
| Dec 4, 2020 | HealthJOINTK202487 · LLZ | 510(k) clearances |
| Dec 4, 2020 | HealthJOINTK202487 · Radiology | AI-enabled devices |
| Jul 16, 2020 | HealthMammoK200905 · QFM | 510(k) clearances |
| Jul 16, 2020 | HealthMammoK200905 · Radiology | AI-enabled devices |
| May 12, 2020 | HealthVCFK192901 · QFM | 510(k) clearances |
| May 12, 2020 | HealthVCFK192901 · Radiology | AI-enabled devices |
| Nov 26, 2019 | HealthCXRK192320 · QFM | 510(k) clearances |
| Nov 26, 2019 | HealthCXRK192320 · Radiology | AI-enabled devices |
| Jun 13, 2019 | HealthICHK190424 · QAS | 510(k) clearances |
| Jun 13, 2019 | HealthICHK190424 · Radiology | AI-enabled devices |
| May 6, 2019 | HealthPNXK190362 · QFM | 510(k) clearances |
| May 6, 2019 | HealthPNXK190362 · 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
