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=K261861

SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A.

Q: How to monitor SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A. 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.

SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A.: 510(k) cleared for Mdsim S.A. Its amount of 103 is below the median of 138 (36th percentile). Dated 51 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 103 · 36th percentile of 414 FDAPulse records · 0.7x the median

Free preview: all 14 published fields of this record are shown below. Locked: 0 related LU FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K261861
Device	SPINEsim v1.0
Applicant	Mdsim S.A.
Specialty / panel	Radiology
Product code	LLZ
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-06-04
Decision date	2026-09-15
Review time (days)	103
Third-party review	No
Applicant location	Esch-Sur-Alzette, LU
amount percentile	36th of 414 (median 138, 0.7x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-15
Data refreshed: 2026-11-04
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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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30 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 103-day review: this device is a strong predicate for similar products.

What is the FDAPulse record for SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A.?

SPINEsim v1.0 (K261861) by Mdsim S.A. was cleared on 2026-09-15 after 103 days of review.

How does SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A. compare to other FDAPulse records?

Its amount of 103 is below the median (36th percentile); smaller records often move faster and face less competition. It is 51 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.

SPINEsim v1.0 (K261861) vs. top 3 peers

Organization	Location	Record date
SPINEsim v1.0 (K261861)	LU	2026-09-15
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 SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A. and peer radiology records

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