Cleared Special

K120718 - INSTAPACS/INSTARISPACS

K120718 is the FDA 510(k) clearance for INSTAPACS/INSTARISPACS by Meddiff Technologies Pvt. , Ltd.. It is a Class 2 Radiology device (product code LLZ) cleared through the Special 510(k) pathway after a 42-day FDA review.

K120718 · Meddiff Technologies Pvt. , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
42d
Days
Class 2
Risk

K120718 is an FDA 510(k) clearance for the INSTAPACS/INSTARISPACS. 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. (Denton, US). The FDA issued a Cleared decision on April 19, 2012 after a review of 42 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. 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. Low regulatory complexity profile. 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 Meddiff Technologies Pvt. , Ltd. devices

Submission Details

510(k) Number K120718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2012
Decision Date April 19, 2012
Days to Decision 42 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
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 1057
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K120718.
QLAB WITH FHN AND VPQ PLUG-IN
K121223 · Philips Ultrasound, Inc. · May 2012
SYNAPSE 3D BRAIN PERFUSION
K120637 · Fujifilm Medical System U.S.A., Inc. · May 2012
SURGICASE CONNECT
K113599 · Materialise NV · Apr 2012
SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION
K120315 · Siemens Medical Solutions USA, Inc. · Apr 2012
SYNAPSE 3D BASE TOOLS
K120361 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2012
GE ECHOPAC
K120221 · Ge Healthcare · Mar 2012