ROBOCOUCH PATIENT SUPPORT SYSTEM— 510(k) K042146

Name: FDA 510(k) clearance K042146
Creator: U.S. Food and Drug Administration
Published: 2004-09-17

Substantially Equivalent

Accuray Incorporated

FDA 510(k) clearance K042146 for ROBOCOUCH PATIENT SUPPORT SYSTEM, Substantially Equivalent on 2004-09-17. Applicant: Accuray Incorporated. Device class: 2.

Clearance details

Applicant: Accuray Incorporated
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 2004-08-09
Decision date: 2004-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K042146

K-number listed on FDA's recall record

Z-1155-2013 — RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.Class II·Terminated·Accuray Incorporated·20130327

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042146.

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