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
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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.

View all Aspyra, Inc. devices

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
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 1315
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K091631.
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
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SYNGO.PLAZA
K093612 · Siemens AG Medical Solutions · Mar 2010
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K092613 · Eizo Nanao Corporation · Mar 2010