Cleared Traditional

PHILIPS CARDIAC WORKSTATION (K922622) - FDA 510(k) Clearance

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

K922622 · Philips Medical Systems, Inc. · Radiology device
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Aug 1992
Decision
69d
Days
Class 2
Risk

K922622 is an FDA 510(k) clearance for the PHILIPS CARDIAC WORKSTATION. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on August 11, 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 Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K922622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1992
Decision Date August 11, 1992
Days to Decision 69 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
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 42
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K922622.
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
POLYTRON DIGITAL IMAGING SYSTEM
K920705 · Siemens Medical Solutions USA, Inc. · Apr 1992
DXS DIGITAL X-RAY SUBTRACTION
K914376 · Philips Medical Systems (Cleveland), Inc. · Feb 1992
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM
K913120 · Siemens Medical Solutions USA, Inc. · Aug 1991