qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd.
qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd. (Indiana): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd. Its amount of 130 is below the median of 138 (49th percentile). Dated 51 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-03, 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: 130 · 49th percentile of 414 FDAPulse records · 0.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 12 related IN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261517 |
| Device | qCT Lung (v1.0) |
| Applicant | Qure.Ai Technologies Pvt. , Ltd. |
| Specialty / panel | Radiology |
| Product code | QDQ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-07 |
| Decision date | 2026-09-14 |
| Review time (days) | 130 |
| Third-party review | No |
| Applicant location | Mumbai, IN |
| amount percentile | 49th of 414 (median 138, 0.9x 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: 2026-09-14
- Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd. and 13 Indiana peers
- Indiana FDAPulse records like this one: 13
- qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd.'s amount: 49th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Indiana peer: $2,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 130-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd. in Indiana?
qCT Lung (v1.0) (K261517) by Qure.Ai Technologies Pvt. , Ltd. was cleared on 2026-09-14 after 130 days of review.
How does qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd. compare to other Indiana FDAPulse records?
Its amount of 130 is below the median (49th 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.
qCT Lung (v1.0) (K261517) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| qCT Lung (v1.0) (K261517) | IN | 2026-09-14 |
| 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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