Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677): 510(k) cleared for Aramis Global AI Consultancies, LLC
Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677): 510(k) cleared for Aramis Global AI Consultancies, LLC: 510(k) cleared for Aramis Global AI Consultancies, LLC. Its amount of 117 is below the median of 138 (43rd percentile). Dated 51 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 117 · 43th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 0 related AE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261677 |
| Device | Artificial Intelligence Renal Assessment (AIRA) Version 1 |
| Applicant | Aramis Global AI Consultancies, LLC |
| Specialty / panel | Radiology |
| Product code | QIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-21 |
| Decision date | 2026-09-15 |
| Review time (days) | 117 |
| Third-party review | No |
| Applicant location | Dubai, AE |
| amount percentile | 43th of 414 (median 138, 0.8x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-15
- Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 117-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677): 510(k) cleared for Aramis Global AI Consultancies, LLC?
Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677) by Aramis Global AI Consultancies, LLC was cleared on 2026-09-15 after 117 days of review.
How does Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677): 510(k) cleared for Aramis Global AI Consultancies, LLC compare to other FDAPulse records?
Its amount of 117 is below the median (43th percentile); smaller records often move faster and face less competition. It is 51 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677) | AE | 2026-09-15 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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