Cleared Traditional

K123408 - ERGO IMAGING SYSTEM

K123408 is an FDA 510(k) clearance for ERGO IMAGING SYSTEM, manufactured by Digirad Corp.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K123408 · Digirad Corp. · Radiology device
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Jan 2013
Decision
71d
Days
Class 1
Risk

K123408 is an FDA 510(k) clearance for the ERGO IMAGING SYSTEM. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Digirad Corp. (Poway, US). The FDA issued a Cleared decision on January 15, 2013 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Digirad Corp. devices

FDA 510(k) Submission Details - K123408

510(k) Number K123408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2012
Decision Date January 15, 2013
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 80
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