Cleared Traditional

K211039 - BIT-Motion (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence.

K211039 · Dde Mri Solutions, Ltd. · Radiology device
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Dec 2021
Decision
252d
Days
Class 2
Risk

K211039 is an FDA 510(k) clearance for the BIT-Motion. 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 Dde Mri Solutions, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on December 15, 2021 after a review of 252 days - an extended review 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-to-high 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 Dde Mri Solutions, Ltd. devices

Submission Details

510(k) Number K211039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2021
Decision Date December 15, 2021
Days to Decision 252 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
145d slower than avg
Panel avg: 107d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John J. Smith

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.

Clinical Evidence

ClinicalTrials.gov
NCT02812589 Completed Interventional

Diffusion Tensor Breast MRI (DTI)

Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)

267
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Breast Cancer
Study design Single group
Eligibility Female only · 18 Years+
Principal investigator Anabel Scaranelo, MD
Sponsor University Health Network, Toronto
Started 2016-04-01 → Primary completion 2020-04-01
Primary outcome
Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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