Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc.
Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc. (Colorado): 510(k) cleared for Ischemaview, Inc. Its amount of 147 is above the median of 138 (55th percentile). Dated 44 days ago, it serves as a historical benchmark. 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: 147 · 55th percentile of 414 FDAPulse records · 1.1x 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 | K261368 |
| Device | Rapid Platform (R6.7) |
| Applicant | Ischemaview, Inc. |
| Specialty / panel | Radiology |
| Product code | QIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-27 |
| Decision date | 2026-09-21 |
| Review time (days) | 147 |
| Third-party review | No |
| Applicant location | Golden, CO, US |
| amount percentile | 55th of 414 (median 138, 1.1x 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: 2026-09-21
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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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 Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc. and 9 Colorado peers
- Colorado FDAPulse records like this one: 9
- Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc.'s amount: 55th percentile of 414 records
- Timing: Low: older than 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 147-day review: this device is a strong predicate for similar products.
- Posted 44 days ago.
What is the FDAPulse record for Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc. in Colorado?
Rapid Platform (R6.7) (K261368) by Ischemaview, Inc. was cleared on 2026-09-21 after 147 days of review.
How does Rapid Platform (R6.7) (K261368): 510(k) cleared for Ischemaview, Inc. compare to other Colorado FDAPulse records?
Its amount of 147 sits in the upper half (55th percentile) of 414 records; the median is 138. It is 44 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 Platform (R6.7) (K261368) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Rapid Platform (R6.7) (K261368) | CO | 2026-09-21 |
| 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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