Cleared Traditional

K920705 - POLYTRON DIGITAL IMAGING SYSTEM

K920705 is the FDA 510(k) clearance for POLYTRON DIGITAL IMAGING SYSTEM by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code IZI) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K920705 · Siemens Medical Solutions USA, Inc. · Radiology device
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Apr 1992
Decision
69d
Days
Class 2
Risk

K920705 is an FDA 510(k) clearance for the POLYTRON DIGITAL IMAGING SYSTEM. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 27, 1992 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K920705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1992
Decision Date April 27, 1992
Days to Decision 69 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
38d faster than avg
Panel avg: 107d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 97
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K920705.
AWOS ANGIOGRAPHIC WORKSTATION
K922804 · Siemens Medical Solutions USA, Inc. · Aug 1992
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HICOR
K914313 · Siemens Gammasonics, Inc. · Nov 1991