Cleared Traditional

K083658 - PACS PLUS 5TH EDITION

K083658 is an FDA 510(k) clearance for PACS PLUS 5TH EDITION, manufactured by Medical Standard Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K083658 · Medical Standard Co., Ltd. · Radiology device
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Jul 2009
Decision
209d
Days
Class 2
Risk

K083658 is an FDA 510(k) clearance for the PACS PLUS 5TH EDITION. 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 Medical Standard Co., Ltd. (Buena Park, US). The FDA issued a Cleared decision on July 7, 2009 after a review of 209 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 Medical Standard Co., Ltd. devices

FDA 510(k) Submission Details - K083658

510(k) Number K083658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2008
Decision Date July 07, 2009
Days to Decision 209 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
102d slower than avg
Panel avg: 107d · This submission: 209d
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 1331
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