Cleared Traditional

K922313 - P-LINK

K922313 is an FDA 510(k) clearance for P-LINK, manufactured by Virtual Imaging. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K922313 · Virtual Imaging · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
70d
Days
Class 2
Risk

K922313 is an FDA 510(k) clearance for the P-LINK. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Virtual Imaging (Sunnyvale, US). The FDA issued a Cleared decision on July 10, 1992 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Virtual Imaging devices

FDA 510(k) Submission Details - K922313

510(k) Number K922313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date July 10, 1992
Days to Decision 70 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
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 331
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K922313.
CARDIAC FIRST PASS ANALYSIS
K921777 · GE Medical Systems · Aug 1992
GENESYS II
K922080 · Adac Laboratories · Jul 1992
GE 4096 PLUS & GE 2048
K914267 · GE Medical Systems · Jul 1992
ECAT EXACT HR MODEL 961
K920624 · Cti Pet Systems, Inc. · Apr 1992
OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
K915470 · General Electric Co. · Apr 1992
APEX HELIX - A
K914807 · Elscint, Inc. · Feb 1992