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Medical device makerAI in United StatesAI. FDA records under 4 spellings of its name, each linked to the record.
- 510(k) clearances: 4
- AI-enabled devices: 3
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jun 22, 2026 | RX-1 SleepK253148 · MNR | 510(k) clearances |
| Jun 22, 2026 | RX-1 SleepK253148 · Anesthesiology | AI-enabled devices |
| Jul 11, 2025 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)K241179 · QYX | 510(k) clearances |
| Sep 2, 2020 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemK200833 · MLO | 510(k) clearances |
| Sep 2, 2020 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemK200833 · Cardiovascular | AI-enabled devices |
| Feb 16, 2019 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemK183704 · DXH | 510(k) clearances |
| Feb 16, 2019 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemK183704 · Cardiovascular | AI-enabled devices |
Names and Identifiers
- Appears as
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