Genesys and the Roi

FDA 510(k) K910002 · The Complete Systems Corp. Genesys

Substantially Equivalent

510(k) numberK910002

Submission

Device name
Genesys and the Roi
Applicant
The Complete Systems Corp. Genesys
Maitland, FL, US
Received
January 2, 1991
Decision date
July 22, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JAI – Couch, Radiation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5770
Specialty
Radiology

Other 510(k)s with product code JAI

510(k)DeviceApplicantDecision
K231612Eve Patient Positioner SystemJAI · Traditional Leo Cancer Care05/07/2024SE
K182683Z-Robot Patient Positioning SystemJAI · Traditional Chinan Biomedical Technology, Inc.06/27/2019SE
K170502Patient Positioning SystemJAI · Special Forte Automation Systems, Inc.04/13/2017SE
K160518LEONI ORION SystemJAI · Traditional Leoni Cia Cable System07/14/2016SE
K132084Protura Couch SoftwareJAI · Traditional Med-Tec, Inc. D/B/A Civco Medical Solutions09/26/2013SE
K122413Patient Positioning SystemJAI · Traditional Forte Automation Systems, Inc.09/13/2012SE
K122201Protura Couch SoftwareJAI · Traditional Med-Tec, Inc. D/B/A Civco Medical Solutions08/30/2012SE
K120520Exactrac Robotics Novalis RoboticsJAI · Traditional Brainlab AG06/29/2012SE
K120916Qfix Radiotherapy ChairJAI · Traditional Wfr/Aquaplast Corp.06/20/2012SE
K072898Hexapod Evo RT Couch TopJAI · Special Medical Intelligence Medizintechnik GmbH10/25/2007SE

Questions and answers

When was Genesys and the Roi cleared by the FDA?

Genesys and the Roi (K910002) received a 510(k) decision of Substantially Equivalent on July 22, 1991, 201 days after the submission was received.

What is the product code of K910002?

The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.