Cleared Traditional

K091631 - ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW

K091631 is an FDA 510(k) clearance for ACCESSNET, manufactured by Aspyra, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K091631 · Aspyra, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
288d
Days
Class 2
Risk

K091631 is an FDA 510(k) clearance for the ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW. 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 Aspyra, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 18, 2010 after a review of 288 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.

FDA 510(k) Submission Details - K091631

510(k) Number K091631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date March 18, 2010
Days to Decision 288 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
181d slower than avg
Panel avg: 107d · This submission: 288d
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 Peers - LLZ System, Image Processing, Radiological

All 2286
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K091631.
SYNAPSE OBLIQUUS MIP/MPR/FUSION
K100881 · Fujifilm Medical System U.S.A., Inc. · Apr 2010
ORS VISUAL
K100335 · Object Research Systems, Inc. · Apr 2010
STAIR SYSTEMS PACS & DICOM VIEWER
K100236 · Stair Systems, Inc. · Mar 2010
SOFTVIEW, MODEL 2.01
K092363 · Riverain Medical Group · Mar 2010
STORM-BASE 2.0
K093603 · KARL STORZ Endoscopy-America, Inc. · Mar 2010
SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)
K092427 · Albert Davydov Dds PC Professional · Mar 2010
K091631 · ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW
Download PDF FDA Summary Aspyra, Inc.