AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.
AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.: 510(k) cleared for Coreline Soft Co., Ltd. Its amount of 252 is above the median of 138 (80th percentile). Dated 20 days ago, it is in the active follow-up window. Score 61/100. 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: 252 · 80th percentile of 414 FDAPulse records · 1.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 31 related KR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260391 |
| Device | AVIEW Aorta Metrics |
| Applicant | Coreline Soft Co., Ltd. |
| Specialty / panel | Radiology |
| Product code | JAK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-06 |
| Decision date | 2026-10-16 |
| Review time (days) | 252 |
| Third-party review | No |
| Applicant location | Seoul, KR |
| amount percentile | 80th of 414 (median 138, 1.8x median) |
| Peer records CSV (32 KR records) | 🔒 Click to unlock → |
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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: 2026-10-16
- 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: AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd. and 32 KR peers
- KR FDAPulse records like this one: 32
- AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.'s amount: 80th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every KR peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 252-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 20 days ago.
What is the FDAPulse record for AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.?
AVIEW Aorta Metrics (K260391) by Coreline Soft Co., Ltd. was cleared on 2026-10-16 after 252 days of review.
How does AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd. compare to other FDAPulse records?
Its amount of 252 sits in the upper half (80th percentile) of 414 records; the median is 138. It is 20 days old, still within a typical 45-day follow-up window.
AVIEW Aorta Metrics (K260391) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| VenusCT (K260510) | CA | 2026-10-19 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
| syngo.CT Brain Quantification (K260055) | TN | 2026-09-25 |
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