Cleared Traditional

K122413 - PATIENT POSITIONING SYSTEM

K122413 is an FDA 510(k) clearance for PATIENT POSITIONING SYSTEM, manufactured by Forte Automation Systems, Inc.. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K122413 · Forte Automation Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
36d
Days
Class 2
Risk

K122413 is an FDA 510(k) clearance for the PATIENT POSITIONING SYSTEM. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Forte Automation Systems, Inc. (Machesney Park, US). The FDA issued a Cleared decision on September 13, 2012 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5770 - 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.

FDA 510(k) Submission Details - K122413

510(k) Number K122413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2012
Decision Date September 13, 2012
Days to Decision 36 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAI Device Classification - Class 2, Special Controls

Product Code JAI Couch, Radiation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5770
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 - JAI Couch, Radiation Therapy, Powered

All 29
Devices cleared under the same product code (JAI) and FDA review panel - the closest regulatory comparables to K122413.
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K122413 · PATIENT POSITIONING SYSTEM
Download PDF FDA Summary Forte Automation Syst…