Cleared Special

K182572 - InstaRISPACS / InstaZFP / InstaMobi v5.0 (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182572 · Meddiff Technologies Pvt. , Ltd. · Radiology device
Apr 2019
Decision
206d
Days
Class 2
Risk

K182572 is an FDA 510(k) clearance for the InstaRISPACS / InstaZFP / InstaMobi v5.0. 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 Meddiff Technologies Pvt. , Ltd. (Bangalore, IN). The FDA issued a Cleared decision on April 12, 2019 after a review of 206 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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.

Submission Details

510(k) Number K182572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2018
Decision Date April 12, 2019
Days to Decision 206 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 128d · This submission: 206d
Pathway characteristics
Modification to existing cleared device.

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 Peers - LLZ System, Image Processing, Radiological

All 126
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