Cleared Traditional

K951947 - MED-TEC RADIO THERAPY TREATMENT CHAIR

K951947 is the FDA 510(k) clearance for MED-TEC RADIO THERAPY TREATMENT CHAIR by Medtec, Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K951947 · Medtec, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
77d
Days
Class 2
Risk

K951947 is an FDA 510(k) clearance for the MED-TEC RADIO THERAPY TREATMENT CHAIR. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on July 12, 1995 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Medtec, Inc. devices

Submission Details

510(k) Number K951947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1995
Decision Date July 12, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 316
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K951947.
MED-TEC REDISET
K952189 · Medtec, Inc. · Aug 1995
MED-TEC TRAY ADAPTER
K950075 · Medtec, Inc. · Jul 1995
MED-TEC TESTICULAR SEPARATOR
K951679 · Medtec, Inc. · Jul 1995
MED-TEC REDI-FOAM
K951808 · Medtec, Inc. · Jul 1995
MED-TEC KNEE CRUTCH
K951717 · Medtec, Inc. · Jun 1995
HIP FIXATION SYSTEM
K950866 · Medtec, Inc. · May 1995