Cleared Traditional

THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010

K050701 · Bionix Development Corp. · Radiology
Apr 2005
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K050701 is an FDA 510(k) clearance for the THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on April 1, 2005, 14 days after receiving the submission on March 18, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K050701 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2005
Decision Date April 01, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

Similar Devices — IYE Accelerator, Linear, Medical

All 727
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · Varian Medical Systems, Inc. · Jan 2026
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
K252188 · Elekta Solutions AB · Jan 2026
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
K254010 · Brainlab SE · Jan 2026
ChartCheck (RADCH V1.6)
K252988 · Radformation, Inc. · Jan 2026
IDENTIFY (5.0)
K252919 · Varian Medical Systems, Inc. · Dec 2025
ZAP-X Radiosurgery System (ZAP-X)
K250392 · Zap Surgical Systems, Inc. · Nov 2025