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=K261623

EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics

Q: How to monitor EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics 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 Wisconsin records like this one.

EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics (Wisconsin): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics. Its amount of 124 is below the median of 138 (46th percentile). Dated 49 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: 124 · 46th percentile of 414 FDAPulse records · 0.9x the median

Free preview: all 14 published fields of this record are shown below. Locked: 3 related WI FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K261623
Device	EchoPAC Software Only / EchoPAC Plug-in (v211)
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics
Specialty / panel	Radiology
Product code	QIH
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-05-15
Decision date	2026-09-16
Review time (days)	124
Third-party review	No
Applicant location	Waukesha, WI, US
amount percentile	46th of 414 (median 138, 0.9x 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: 2026-11-04
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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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Peer benchmark and outreach value: EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics and 4 Wisconsin peers

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

Wisconsin FDAPulse records like this one: 4
EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics's amount: 46th percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every Wisconsin peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

30 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 124-day review: this device is a strong predicate for similar products.

What is the FDAPulse record for EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics in Wisconsin?

EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623) by GE Medical Systems Ultrasound and Primary Care Diagnostics was cleared on 2026-09-16 after 124 days of review.

How does EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics compare to other Wisconsin FDAPulse records?

Its amount of 124 is below the median (46th percentile); smaller records often move faster and face less competition. It is 49 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.

EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623) vs. top 3 peers

Organization	Location	Record date
EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623)	WI	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

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How to monitor EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics and peer radiology records

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