Cleared Traditional

K163158 - MEDSYNAPSE Zero Footprint Viewer

K163158 is an FDA 510(k) clearance for MEDSYNAPSE Zero Footprint Viewer, manufactured by Medsynaptic Private, Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K163158 · Medsynaptic Private, Ltd. · Radiology device
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Dec 2016
Decision
22d
Days
Class 2
Risk

K163158 is an FDA 510(k) clearance for the MEDSYNAPSE Zero Footprint Viewer. 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 Medsynaptic Private, Ltd. (Pune, IN). The FDA issued a Cleared decision on December 2, 2016 after a review of 22 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 Medsynaptic Private, Ltd. devices

FDA 510(k) Submission Details - K163158

510(k) Number K163158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2016
Decision Date December 02, 2016
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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

Kamm & Associates
Daniel Kamm

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.

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