CLEARVUE PRONE BREAST TREATMENT TABLE— 510(k) K090349

Name: FDA 510(k) clearance K090349
Creator: U.S. Food and Drug Administration
Published: 2009-03-09

Substantially Equivalent

Orbital Therapy, LLC

FDA 510(k) clearance K090349 for CLEARVUE PRONE BREAST TREATMENT TABLE, Substantially Equivalent on 2009-03-09. Applicant: Orbital Therapy, LLC. Device class: 2.

Clearance details

Applicant: Orbital Therapy, LLC
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2009-02-11
Decision date: 2009-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winchester, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYE

view all

K261718 — EZFluence (RADEZ V2)2026-08-31
K260733 — MRIA Radiation Therapy Information System (MRIA)2026-08-26
K261856 — Halcyon, Ethos Radiotherapy System (5.0)2026-08-03
K252937 — ThinkQA 32026-06-12
K253004 — LUNA 3D2026-06-04

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K090349

K-number listed on FDA's recall record

Z-1264-2016 — Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning.Class II·Terminated·Wfr/aquaplast Corp·20160107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090349.

Data sourced from openFDA. This site is unofficial and independent of the FDA.