FDA 510(k)

Z-Robot Patient Positioning System

K-Number: K182683 · 2019-06-27

ApplicantChinan Biomedical Technology, Inc.

Decision Date2019-06-27

Product CodeJAI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Z-Robot Patient Positioning System is the device name listed in this FDA 510(k) record. The listed applicant is Chinan Biomedical Technology, Inc.. It received FDA 510(k) clearance on 2019-06-27 under 510(k) number K182683. 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 Z-Robot Patient Positioning System?

Z-Robot Patient Positioning System is a medical device that received FDA 510(k) clearance on 2019-06-27. The listed applicant is Chinan Biomedical Technology, Inc.. The 510(k) number is K182683.

When did Z-Robot Patient Positioning System receive FDA 510(k) clearance?

Z-Robot Patient Positioning System received FDA 510(k) clearance on 2019-06-27, under 510(k) number K182683.

Who is the listed applicant for Z-Robot Patient Positioning System?

The FDA 510(k) record lists Chinan Biomedical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Z-Robot Patient Positioning System?

The FDA product code for Z-Robot Patient Positioning System is JAI.

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 Care 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.