Cleared Traditional

CSP-A (CEILING SUSPENDED POSITIONER-ANGIO) (K924137) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924137 · Fischer Imaging Corp. · Radiology device
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Dec 1992
Decision
132d
Days
Class 2
Risk

K924137 is an FDA 510(k) clearance for the CSP-A (CEILING SUSPENDED POSITIONER-ANGIO). Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 132 days - within the typical 510(k) review window.

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: 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 Fischer Imaging Corp. devices

Submission Details

510(k) Number K924137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1992
Decision Date December 28, 1992
Days to Decision 132 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 107d · This submission: 132d
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 46
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K924137.
MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM
K930635 · Siemens Medical Solutions USA, Inc. · Sep 1993
DLX
K926258 · GE Medical Systems · Mar 1993
ANCOR
K924719 · Siemens Medical Solutions USA, Inc. · Dec 1992
ANGIOGRAPHIC X-RAY SYSTEM
K922222 · Siemens Medical Solutions USA, Inc. · Dec 1992
ANGIO-BAND
K923112 · Cook, Inc. · Sep 1992
AWOS ANGIOGRAPHIC WORKSTATION
K922804 · Siemens Medical Solutions USA, Inc. · Aug 1992