Cleared Traditional

K083673 - CARESTREAM PACS

K083673 is the FDA 510(k) clearance for CARESTREAM PACS by Carestream Health, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K083673 · Carestream Health, Inc. · Radiology device
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Dec 2008
Decision
19d
Days
Class 2
Risk

K083673 is an FDA 510(k) clearance for the CARESTREAM PACS, MODEL CARESTREAM PACS VII. 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 Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on December 30, 2008 after a review of 19 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 Carestream Health, Inc. devices

Submission Details

510(k) Number K083673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2008
Decision Date December 30, 2008
Days to Decision 19 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
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K083673.
MAMMODIAGNOST VU
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K083149 · Siemens Medical Solutions USA, Inc. · Jan 2009
SYNGO IMAGING XS
K082430 · Siemens AG Medical Solutions · Nov 2008
4D VIEWER RADIOLOGY, MODEL USWP-100A
K082684 · Toshiba America Medical Systems, In.C · Oct 2008
COLOR LCD MONITOR
K082663 · Eizo Nanao Corporation · Oct 2008