FDA 510(k)

Eve Patient Positioner System

K-Number: K231612 · 2024-05-07

Decision Date2024-05-07

Product CodeJAI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Eve Patient Positioner System is the device name listed in this FDA 510(k) record. The listed applicant is Leo Cancer Care. It received FDA 510(k) clearance on 2024-05-07 under 510(k) 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. The listed applicant is Leo Cancer Care. The 510(k) number is K231612.

When did Eve Patient Positioner System receive FDA 510(k) clearance?

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

Who is the listed applicant for Eve Patient Positioner System?

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

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

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

Other records listing Leo Cancer Care 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.

K250970Marie

Related Devices (Code: JAI)

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

Official Source

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