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FDA 510(k)

Eve Patient Positioner System

K-Number: K231612 · 2024-05-07

ApplicantLeo Cancer Care
Decision Date2024-05-07
Product CodeJAI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Eve Patient Positioner System is a medical device manufactured by Leo Cancer Care. It received FDA 510(k) clearance on 2024-05-07 under approval number K231612. 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 Eve Patient Positioner System?

Eve Patient Positioner System is a medical device that received FDA 510(k) clearance on 2024-05-07. It is manufactured by Leo Cancer Care. The 510(k) number is K231612.

When was Eve Patient Positioner System approved by the FDA?

Eve Patient Positioner System received FDA 510(k) clearance on 2024-05-07, under approval number K231612.

What company makes Eve Patient Positioner System?

Eve Patient Positioner System is manufactured by Leo Cancer Care.

What is the FDA product code for Eve Patient Positioner System?

The FDA product code for Eve Patient Positioner System is JAI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Leo Cancer Care

K250970Marie

Related Devices (Code: JAI)

K160518LEONI ORION SystemLeoni Cia Cable System K170502Patient Positioning SystemForte Automation Systems, Inc. K182683Z-Robot Patient Positioning SystemChinan Biomedical Technology, 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.

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