Cleared Traditional

K902848 - FASTRECON 88 PERIFERAL

K902848 is an FDA 510(k) clearance for FASTRECON 88 PERIFERAL, manufactured by Scientific Technology , Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K902848 · Scientific Technology , Ltd. · Radiology device
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Aug 1990
Decision
34d
Days
Class 2
Risk

K902848 is an FDA 510(k) clearance for the FASTRECON 88 PERIFERAL. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Scientific Technology , Ltd. (Garland, US). The FDA issued a Cleared decision on August 1, 1990 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Scientific Technology , Ltd. devices

FDA 510(k) Submission Details - K902848

510(k) Number K902848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1990
Decision Date August 01, 1990
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 107d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 757
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K902848.
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TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
K896456 · Toshiba America Medical Systems, In.C · Mar 1990