Cleared Traditional

ERGO IMAGING SYSTEM

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

About This 510(k) Submission

K123408 is an FDA 510(k) clearance for the ERGO IMAGING SYSTEM, a Camera, Scintillation (gamma) (Class I — General Controls, product code IYX), submitted by Digirad Corp. (Poway, US). The FDA issued a Cleared decision on January 15, 2013, 71 days after receiving the submission on November 5, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number K123408 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IYX — Camera, Scintillation (gamma)
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1100

Similar Devices — IYX Camera, Scintillation (gamma)

All 129
QDOSE? Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
K230221 · Versant Medical Physics and Radiation Safety · Aug 2023
3D-RD-S
K212587 · Radiopharmaceutical Imaging and Dosimetry, LLC · Feb 2023
OLINDA EXM
K163687 · Hermes Medical Solutions AB · Jul 2017
Discovery NM 750b Bopsy
K160933 · Ge Healthcare · Nov 2016
Sentinella 102, Sentinella 102 Horus
K162052 · General Equipment For Medical Imaging (Oncovision- · Aug 2016
Sentinella 102; Sentinella 102 Horus
K143156 · General Equipment For Medical Imaging (Oncovision- · Nov 2014