Cleared Traditional

K083618 - PACS SCAN

K083618 is an FDA 510(k) clearance for PACS SCAN, manufactured by Pacsgear, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K083618 · Pacsgear, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
51d
Days
Class 2
Risk

K083618 is an FDA 510(k) clearance for the PACS SCAN. 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 Pacsgear, Inc. (Austin, US). The FDA issued a Cleared decision on January 28, 2009 after a review of 51 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. 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 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 Pacsgear, Inc. devices

FDA 510(k) Submission Details - K083618

510(k) Number K083618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2008
Decision Date January 28, 2009
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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 1334
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K083618.
NIO COLOR 3MP AND MDNC-3121
K090732 · Barco N.V. · Apr 2009
UROCARE
K090552 · Neusoft Medical Systems Co., Ltd. · Mar 2009
MAMMODIAGNOST VU
K083740 · Philips Medical Systems Nederland B.V. · Feb 2009
COLOR LCD MONITOR, RADIFORCE RX320
K090045 · Eizo Nanao Corporation · Jan 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · Siemens Medical Solutions USA, Inc. · Jan 2009
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · Carestream Health, Inc. · Dec 2008