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=K260523

QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV

Q: How to monitor QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV 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.

QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV: 510(k) cleared for Medis Medical Imaging Systems BV. Its amount of 230 is above the median of 138 (73rd percentile). Dated 30 days ago, it is in the active follow-up window. Score 48/100. 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: 230 · 73th percentile of 414 FDAPulse records · 1.7x the median

Free preview: all 14 published fields of this record are shown below. Locked: 2 related NL FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K260523
Device	QGuideCT (1.0)
Applicant	Medis Medical Imaging Systems BV
Specialty / panel	Radiology
Product code	QIH
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-02-17
Decision date	2026-10-05
Review time (days)	230
Third-party review	No
Applicant location	Leiden, NL
amount percentile	73th of 414 (median 138, 1.7x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-05
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: QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV and 3 NL peers

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

NL FDAPulse records like this one: 3
QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV's amount: 73rd percentile of 414 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every NL peer: $600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

48 / 100 Predicate Speed & CAPA Advisory Opportunity Score

230-day review, longer than typical.
Posted 30 days ago.

What is the FDAPulse record for QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV?

QGuideCT (1.0) (K260523) by Medis Medical Imaging Systems BV was cleared on 2026-10-05 after 230 days of review.

How does QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV compare to other FDAPulse records?

Its amount of 230 sits in the upper half (73th percentile) of 414 records; the median is 138. It is 30 days old, still within a typical 45-day follow-up window.

QGuideCT (1.0) (K260523) vs. top 3 peers

Organization	Location	Record date
QGuideCT (1.0) (K260523)	NL	2026-10-05
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 QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV and peer radiology records

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