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FDA 510(k)

TOTIM Patient Cushion Immobilization System

K-Number: K190894 · 2019-04-30

ApplicantEssebi Medical Srl
Decision Date2019-04-30
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOTIM Patient Cushion Immobilization System is the device name listed in this FDA 510(k) record. The listed applicant is Essebi Medical Srl. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K190894. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTIM Patient Cushion Immobilization System?

TOTIM Patient Cushion Immobilization System is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Essebi Medical Srl. The 510(k) number is K190894.

When did TOTIM Patient Cushion Immobilization System receive FDA 510(k) clearance?

TOTIM Patient Cushion Immobilization System received FDA 510(k) clearance on 2019-04-30, under 510(k) number K190894.

Who is the listed applicant for TOTIM Patient Cushion Immobilization System?

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

What is the FDA product code for TOTIM Patient Cushion Immobilization System?

The FDA product code for TOTIM Patient Cushion Immobilization System is IYE.

Related Devices (Code: IYE)

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, 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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