HEXAPOD EVO RT COUCH TOP— 510(k) K072898

Name: FDA 510(k) clearance K072898
Creator: U.S. Food and Drug Administration
Published: 2007-10-25

Substantially Equivalent

Medical Intelligence Medizintechnik GmbH

FDA 510(k) clearance K072898 for HEXAPOD EVO RT COUCH TOP, Substantially Equivalent on 2007-10-25. Applicant: Medical Intelligence Medizintechnik GmbH. Device class: 2.

Clearance details

Applicant: Medical Intelligence Medizintechnik GmbH
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 2007-10-11
Decision date: 2007-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Schwabmuenchen, DE

Download summary PDF View on FDA.gov ↗

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Recalls naming K072898

K-number listed on FDA's recall record

Z-2535-2018 — HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapyClass II·Terminated·Elekta, Inc.·20180516
Z-1514-2014 — HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.Class II·Terminated·Elekta, Inc.·20140417

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072898.

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