Cleared Traditional

IMAGE PROCESSING SYS A3

K832505 · Metronic, Inc. · Radiology
Sep 1983
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K832505 is an FDA 510(k) clearance for the IMAGE PROCESSING SYS A3, a Camera, Scintillation (gamma) (Class I — General Controls, product code IYX), submitted by Metronic, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 47 days after receiving the submission on July 27, 1983. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number K832505 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1983
Decision Date September 12, 1983
Days to Decision 47 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

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