Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ROBOCOUCH PATIENT SUPPORT SYSTEM

K-Number: K042146 · 2004-09-17

ApplicantAccuray Incorporated
Decision Date2004-09-17
Product CodeJAI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ROBOCOUCH PATIENT SUPPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accuray Incorporated. It received FDA 510(k) clearance on 2004-09-17 under 510(k) number K042146. The device is classified under product code JAI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROBOCOUCH PATIENT SUPPORT SYSTEM?

ROBOCOUCH PATIENT SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-17. The listed applicant is Accuray Incorporated. The 510(k) number is K042146.

When did ROBOCOUCH PATIENT SUPPORT SYSTEM receive FDA 510(k) clearance?

ROBOCOUCH PATIENT SUPPORT SYSTEM received FDA 510(k) clearance on 2004-09-17, under 510(k) number K042146.

Who is the listed applicant for ROBOCOUCH PATIENT SUPPORT SYSTEM?

The FDA 510(k) record lists Accuray Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROBOCOUCH PATIENT SUPPORT SYSTEM?

The FDA product code for ROBOCOUCH PATIENT SUPPORT SYSTEM is JAI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Accuray Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223159Radixact Treatment Delivery SystemK212794Accuray Precision Treatment Planning SystemK202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemK182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemK171837TomoTherapy Treatment Delivery System with iDMSK171086Accuray Precision Treatment Planning System

View all 18 devices →

Related Devices (Code: JAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231612Eve Patient Positioner SystemLeo Cancer CareK182683Z-Robot Patient Positioning SystemChinan Biomedical Technology, Inc.K170502Patient Positioning SystemForte Automation Systems, Inc.K160518LEONI ORION SystemLeoni Cia Cable SystemK132084PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical SolutionsK122413PATIENT POSITIONING SYSTEMForte Automation Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑