Cleared Traditional

K852284 - DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAG...

K852284 is the FDA 510(k) clearance for DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAG... by Digirad Corp.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K852284 · Digirad Corp. · Radiology device
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Nov 1985
Decision
169d
Days
Class 2
Risk

K852284 is an FDA 510(k) clearance for the DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA. 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 Digirad Corp. (Palo Alto, US). The FDA issued a Cleared decision on November 14, 1985 after a review of 169 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 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 Digirad Corp. devices

Submission Details

510(k) Number K852284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date November 14, 1985
Days to Decision 169 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 107d · This submission: 169d
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 1128
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