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.. FDA records under 10 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list iSchemaView with 26 510(k) clearances and 20 AI-enabled devices. The most recent is a 510(k) clearance dated Oct 9, 2026: Rapid ICH (v4.0).
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.
| Date | Record | Source |
|---|---|---|
| Oct 9, 2026 | Rapid ICH (v4.0)K262301 · QAS | 510(k) clearances |
| Sep 21, 2026 | Rapid Platform (R6.7)K261368 · QIH | 510(k) clearances |
| Jul 13, 2026 | Rapid Vessel Occlusion (Rapid VO)K261085 · QAS | 510(k) clearances |
| Sep 23, 2025 | Rapid Aortic MeasurementsK251987 · QIH | 510(k) clearances |
| Sep 23, 2025 | Rapid Aortic MeasurementsK251987 · Radiology | AI-enabled devices |
| Sep 4, 2025 | Rapid Obstructive Hydrocephalus, Rapid OHK251533 · QAS | 510(k) clearances |
| Sep 4, 2025 | Rapid Obstructive Hydrocephalus, Rapid OHK251533 · Radiology | AI-enabled devices |
| Aug 26, 2025 | Rapid DeltaFuseK252526 · LLZ | 510(k) clearances |
| Jul 16, 2025 | Rapid CTA 360K251151 · QAS | 510(k) clearances |
| Jul 16, 2025 | Rapid CTA 360K251151 · Radiology | AI-enabled devices |
| May 28, 2025 | Rapid MLSK243378 · QIH | 510(k) clearances |
| May 28, 2025 | Rapid MLSK243378 · Radiology | AI-enabled devices |
| Jan 22, 2025 | Rapid Neuro3DK243350 · Radiology | AI-enabled devices |
| Apr 22, 2024 | RapidK233582 · Radiology | AI-enabled devices |
| Jan 19, 2024 | Rapid ASPECTS (v3)K232156 · Radiology | AI-enabled devices |
| Jan 16, 2024 | Rapid (6.0)K233512 · 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
