Cleared Traditional

CARDIAC CAMERA (K833811) - FDA 510(k) Clearance

Class I Radiology device.

K833811 · Siemens Gammasonics, Inc. · Radiology device
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Dec 1983
Decision
104d
Days
Class 1
Risk

K833811 is an FDA 510(k) clearance for the CARDIAC CAMERA. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Siemens Gammasonics, Inc. (Walker, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Gammasonics, Inc. devices

Submission Details

510(k) Number K833811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1983
Decision Date December 27, 1983
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 29
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