Cleared Traditional

K810873 - STAR

K810873 is the FDA 510(k) clearance for STAR by Intl. General Electric Co.. It is a Class 2 Radiology device (product code JWM) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K810873 · Intl. General Electric Co. · Radiology device
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Apr 1981
Decision
23d
Days
Class 2
Risk

K810873 is an FDA 510(k) clearance for the STAR. Classified as System, Tomographic, Nuclear (product code JWM), Class II - Special Controls.

Submitted by Intl. General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1310 - 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 Intl. General Electric Co. devices

Submission Details

510(k) Number K810873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1981
Decision Date April 23, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWM System, Tomographic, Nuclear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1310
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 - JWM System, Tomographic, Nuclear

All 15
Devices cleared under the same product code (JWM) and FDA review panel - the closest regulatory comparables to K810873.
DOT-A, DOT-AR PXP-E, PXP-ER
K841905 · Siemens Gammasonics, Inc. · Aug 1984
ECT PROCESSOR
K832737 · Siemens Gammasonics, Inc. · Sep 1983
400T ECT SOFTWARE
K812966 · General Electric Co. · Nov 1981
STAR
K801917 · General Electric Co. · Sep 1980
MODUMED MUGX
K780368 · Medtronic Vascular · Mar 1978
MODUMED MUGE
K780369 · Medtronic Vascular · Mar 1978