Cleared Traditional

K202256 - 3Shape Implant Studio

K202256 is the FDA 510(k) clearance for 3Shape Implant Studio by 3Shape Medical A/S. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K202256 · 3Shape Medical A/S · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
30d
Days
Class 2
Risk

K202256 is an FDA 510(k) clearance for the 3Shape Implant Studio. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by 3Shape Medical A/S (Copenhagen, DK). The FDA issued a Cleared decision on September 9, 2020 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all 3Shape Medical A/S devices

Submission Details

510(k) Number K202256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2020
Decision Date September 09, 2020
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 Consultant

Accelerated Device Approval Services
Rafael Aguila

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1056
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K202256.
Collaboration Live
K201665 · Philips Ultrasound, Inc. · Sep 2020
Aline Ablation Intelligence
K202297 · Mirada Medical, Ltd. · Sep 2020
AcroDTI Visualizer
K201948 · Acroviz, Inc. · Sep 2020
Ambra ProViewer
K202335 · Dicom Grid Inc Dba Ambra Health · Sep 2020
Synapse 3D Cardiac Tools
K200973 · Fujifilm Corporaton · Aug 2020
AVIEW
K200714 · Coreline Soft Co., Ltd. · Aug 2020