Cleared Traditional

K201555 - EchoGo Pro

K201555 is the FDA 510(k) clearance for EchoGo Pro by Ultromics, Ltd.. It is a Class 2 Radiology device (product code POK) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K201555 · Ultromics, Ltd. · Radiology device
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Dec 2020
Decision
191d
Days
Class 2
Risk

K201555 is an FDA 510(k) clearance for the EchoGo Pro. Classified as Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK), Class II - Special Controls.

Submitted by Ultromics, Ltd. (Oxford, GB). The FDA issued a Cleared decision on December 18, 2020 after a review of 191 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2060 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ultromics, Ltd. devices

Submission Details

510(k) Number K201555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2020
Decision Date December 18, 2020
Days to Decision 191 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 107d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2060
Definition Assist Users In Characterizing Lesions Identified On Acquired Medical Images
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

All 20
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