Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc.
Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc. (Colorado): 510(k) cleared for Ischemaview, Inc. Its amount of 94 is below the median of 138 (33rd percentile). Dated 26 days ago, it is in the active follow-up window. Score 36/100. 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: 94 · 33th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related CO FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262301 |
| Device | Rapid ICH (v4.0) |
| Applicant | Ischemaview, Inc. |
| Specialty / panel | Radiology |
| Product code | QAS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-07 |
| Decision date | 2026-10-09 |
| Review time (days) | 94 |
| Third-party review | No |
| Applicant location | Golden, CO, US |
| amount percentile | 33th of 414 (median 138, 0.7x 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: 2026-10-09
- 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: Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc. and 9 Colorado peers
- Colorado FDAPulse records like this one: 9
- Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc.'s amount: 33rd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Colorado peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 94-day review: this device is a strong predicate for similar products.
- Posted 26 days ago.
What is the FDAPulse record for Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc. in Colorado?
Rapid ICH (v4.0) (K262301) by Ischemaview, Inc. was cleared on 2026-10-09 after 94 days of review.
How does Rapid ICH (v4.0) (K262301): 510(k) cleared for Ischemaview, Inc. compare to other Colorado FDAPulse records?
Its amount of 94 is below the median (33th percentile); smaller records often move faster and face less competition. It is 26 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Rapid ICH (v4.0) (K262301) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Rapid ICH (v4.0) (K262301) | CO | 2026-10-09 |
| 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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