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=K262548

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC

Q: How to monitor EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC 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 Washington records like this one.

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC (Washington): 510(k) cleared for Philips Ultrasound, LLC. Its amount of 64 is below the median of 138 (19th percentile). Dated 40 days ago, it serves as a historical benchmark. Score 36/100. 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: 64 · 19th percentile of 414 FDAPulse records · 0.5x the median

Free preview: all 14 published fields of this record are shown below. Locked: 16 related WA FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K262548
Device	EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Applicant	Philips Ultrasound, LLC
Specialty / panel	Radiology
Product code	IYN
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-07-23
Decision date	2026-09-25
Review time (days)	64
Third-party review	No
Applicant location	Bothell, WA, US
amount percentile	19th of 414 (median 138, 0.5x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-25
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: EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC and 17 Washington peers

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

Washington FDAPulse records like this one: 17
EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC's amount: 19th percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every Washington peer: $3,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

36 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 64-day review: this device is a strong predicate for similar products.
Posted 40 days ago.

What is the FDAPulse record for EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC in Washington?

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548) by Philips Ultrasound, LLC was cleared on 2026-09-25 after 64 days of review.

How does EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC compare to other Washington FDAPulse records?

Its amount of 64 is below the median (19th percentile); smaller records often move faster and face less competition. It is 40 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.

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548) vs. top 3 peers

Organization	Location	Record date
EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548)	WA	2026-09-25
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 EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC and peer radiology records

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