Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd.
Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd. (Illinois): 510(k) cleared for Aspect Imaging, Ltd. Its amount of 111 is below the median of 138 (41st percentile). Dated 50 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: 111 · 41th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261758 |
| Device | Embrace Vision Neonatal MRI System |
| Applicant | Aspect Imaging, Ltd. |
| Specialty / panel | Radiology |
| Product code | LNH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-28 |
| Decision date | 2026-09-16 |
| Review time (days) | 111 |
| Third-party review | No |
| Applicant location | Shoham, IL |
| amount percentile | 41th 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: 2026-09-16
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd. and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd.'s amount: 41st percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 111-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd. in Illinois?
Embrace Vision Neonatal MRI System (K261758) by Aspect Imaging, Ltd. was cleared on 2026-09-16 after 111 days of review.
How does Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd. compare to other Illinois FDAPulse records?
Its amount of 111 is below the median (41th percentile); smaller records often move faster and face less competition. It is 50 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.
Embrace Vision Neonatal MRI System (K261758) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Embrace Vision Neonatal MRI System (K261758) | IL | 2026-09-16 |
| 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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