Home / 510(k) Clearances / K040773

510(k) K040773

PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM by Bionix Development Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2004
Date Received
March 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Bionix Development Corp.

  • K153270 — TruGuard Custom Tongue and Jaw Positioner (March 8, 2016)
  • K123411 — LITTLE ANGELS SWADDLING BLANKET (March 7, 2013)
  • K120335 — EMBRACE THERMOPLASTIC (May 3, 2012)
  • K100691 — OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 (May 11, 2010)
  • K100264 — T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 (April 9, 2010)
  • K050701 — THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 (April 1, 2005)
  • K030051 — VERSABOARD, MODEL 7040 (April 4, 2003)
  • K933614 — PITUITARY BOARD (October 7, 1993)
  • K933613 — 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER (October 7, 1993)
  • K905007 — STANDARD BREAST BOARDS; DELUXE BREAST BOARD (February 12, 1991)

Other clearances for product code IYE

  • K252977 — Halcyon, Ethos Radiotherapy System (5.0) (January 21, 2026)
  • K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infin (January 15, 2026)
  • K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (January 14, 2026)
  • K252988 — ChartCheck (RADCH V1.6) (January 5, 2026)
  • K252919 — IDENTIFY (5.0) (December 16, 2025)
  • K250392 — ZAP-X Radiosurgery System (ZAP-X) (November 3, 2025)
  • K250696 — AccuCheck (October 24, 2025)
  • K250911 — MOSkin Radiation Measurement System (October 17, 2025)
  • K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam (October 7, 2025)
  • K252174 — AquaCast Mask (September 3, 2025)