Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261943

REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc.

Q: How to monitor REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc. and peer radiology records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc.: 510(k) cleared for Remedi, Inc. Its amount of 114 is below the median of 138 (41st percentile). Dated 33 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 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 114 · 41th percentile of 414 FDAPulse records · 0.8x 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	K261943
Device	REMEX-T(K)100C
Applicant	Remedi, Inc.
Specialty / panel	Radiology
Product code	IZL
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-06-10
Decision date	2026-10-02
Review time (days)	114
Third-party review	No
Applicant location	Seoul, KR
amount percentile	41th of 414 (median 138, 0.8x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-02
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: REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc. and 32 KR peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

KR FDAPulse records like this one: 32
REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc.'s amount: 41st percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every KR peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

36 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 114-day review: this device is a strong predicate for similar products.
Posted 33 days ago.

What is the FDAPulse record for REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc.?

REMEX-T(K)100C (K261943) by Remedi, Inc. was cleared on 2026-10-02 after 114 days of review.

How does REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc. compare to other FDAPulse records?

Its amount of 114 is below the median (41th percentile); smaller records often move faster and face less competition. It is 33 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.

REMEX-T(K)100C (K261943) vs. top 3 peers

Organization	Location	Record date
REMEX-T(K)100C (K261943)	KR	2026-10-02
VenusCT (K260510)	CA	2026-10-19
AVIEW Aorta Metrics (K260391)	KR	2026-10-16
Vista AI Scan (K260092)	CA	2026-10-07

How to monitor REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc. and peer radiology records

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