Cleared Traditional

K221347 - Transpara 1.7.2 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221347 · Screenpoint Medical B.V. · Radiology device
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Aug 2022
Decision
86d
Days
Class 2
Risk

K221347 is an FDA 510(k) clearance for the Transpara 1.7.2. Classified as Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer (product code QDQ), Class II - Special Controls.

Submitted by Screenpoint Medical B.V. (Nijmegen, NL). The FDA issued a Cleared decision on August 3, 2022 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2090 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Screenpoint Medical B.V. devices

Submission Details

510(k) Number K221347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2022
Decision Date August 03, 2022
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QDQ Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2090
Definition A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Lesions Is An Image Processing Device Intended To Aid In The Detection, Localization, And Characterization Of Lesions Suspicious For Cancer On Acquired Medical Images (e.g., Mammography , Mr, Ct, Ultrasound, Radiography). The Device Detects, Identifies And Characterizes Lesions Suspicious For Cancer Based On Features Or Information Extracted From The Images, And May Provide Information About The Presence, Location, And Characteristics Of The Lesion To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User.
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 - QDQ Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

All 33
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