Cleared Traditional

K910648 - THERAPY CHAIR SYSTEM

K910648 is an FDA 510(k) clearance for THERAPY CHAIR SYSTEM, manufactured by Radiation Technology, Inc.. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K910648 · Radiation Technology, Inc. · Radiology device
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Jul 1991
Decision
158d
Days
Class 2
Risk

K910648 is an FDA 510(k) clearance for the THERAPY CHAIR SYSTEM. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Radiation Technology, Inc. (Brisbane, Queensland, AU). The FDA issued a Cleared decision on July 22, 1991 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Radiation Technology, Inc. devices

FDA 510(k) Submission Details - K910648

510(k) Number K910648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1991
Decision Date July 22, 1991
Days to Decision 158 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 107d · This submission: 158d
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.