PATIENT POSITIONING SYSTEM— 510(k) K122413

Name: FDA 510(k) clearance K122413
Creator: U.S. Food and Drug Administration
Published: 2012-09-13

Substantially Equivalent

Forte Automation Systems, Inc.

FDA 510(k) clearance K122413 for PATIENT POSITIONING SYSTEM, Substantially Equivalent on 2012-09-13. Applicant: Forte Automation Systems, Inc.. Device class: 2.

Clearance details

Applicant: Forte Automation Systems, Inc.
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 2012-08-08
Decision date: 2012-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Machesney Park, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K122413

K-number listed on FDA's recall record

Z-2537-2018 — Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.Class II·Terminated·Forte Automation Systems Inc·20170905

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122413.

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