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=K261283

APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation

Q: How to monitor APERTO Lucent MRI System (K261283): 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.

APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation: 510(k) cleared for Fujifilm Corporation. Its amount of 152 is above the median of 138 (56th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 42/100. 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: 152 · 56th percentile of 414 FDAPulse records · 1.1x 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	K261283
Device	APERTO Lucent MRI System
Applicant	Fujifilm Corporation
Specialty / panel	Radiology
Product code	LNH
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-04-17
Decision date	2026-09-16
Review time (days)	152
Third-party review	No
Applicant location	Minato-Ku, JP
amount percentile	56th of 414 (median 138, 1.1x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-16
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: APERTO Lucent MRI System (K261283): 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
APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation's amount: 56th percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every JP peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

42 / 100 Predicate Speed & CAPA Advisory Opportunity Score

152-day review, longer than typical.

What is the FDAPulse record for APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation?

APERTO Lucent MRI System (K261283) by Fujifilm Corporation was cleared on 2026-09-16 after 152 days of review.

How does APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation compare to other FDAPulse records?

Its amount of 152 sits in the upper half (56th percentile) of 414 records; the median is 138. It is 49 days old; check the official source for later updates before acting.

APERTO Lucent MRI System (K261283) vs. top 3 peers

Organization	Location	Record date
APERTO Lucent MRI System (K261283)	JP	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

How to monitor APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation and peer radiology records

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