Cleared Traditional

K191705 - OptikView GUP2103CMI

K191705 is the FDA 510(k) clearance for OptikView GUP2103CMI by The Linden Group Corp. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K191705 · The Linden Group Corp · Radiology device
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Mar 2020
Decision
264d
Days
Class 2
Risk

K191705 is an FDA 510(k) clearance for the OptikView GUP2103CMI. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by The Linden Group Corp (Cedar Knolls, US). The FDA issued a Cleared decision on March 16, 2020 after a review of 264 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: 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 The Linden Group Corp devices

Submission Details

510(k) Number K191705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2019
Decision Date March 16, 2020
Days to Decision 264 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
157d slower than avg
Panel avg: 107d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
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

Qubyx Software Technologies, Inc.
Marc Leppla

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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