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=K262902

ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation

Q: How to monitor ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation 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.

ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation: 510(k) cleared for Fujifilm Corporation. Its amount of 52 is below the median of 138 (12th 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 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 52 · 12th percentile of 414 FDAPulse records · 0.4x the median

Free preview: all 14 published fields of this record are shown below. Locked: 9 related JP FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K262902
Device	ECHELON Synergy
Applicant	Fujifilm Corporation
Specialty / panel	Radiology
Product code	LNH
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-08-18
Decision date	2026-10-09
Review time (days)	52
Third-party review	No
Applicant location	Minato-Ku, JP
amount percentile	12th of 414 (median 138, 0.4x median)
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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: ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation and 10 JP peers

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

JP FDAPulse records like this one: 10
ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation's amount: 12th percentile of 414 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every JP peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

36 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 52-day review: this device is a strong predicate for similar products.
Posted 26 days ago.

What is the FDAPulse record for ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation?

ECHELON Synergy (K262902) by Fujifilm Corporation was cleared on 2026-10-09 after 52 days of review.

How does ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation compare to other FDAPulse records?

Its amount of 52 is below the median (12th 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.

ECHELON Synergy (K262902) vs. top 3 peers

Organization	Location	Record date
ECHELON Synergy (K262902)	JP	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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