TOTIM Patient Cushion Immobilization System

FDA 510(k) K190894 · Essebi Medical Srl

Substantially Equivalent

510(k) numberK190894

Submission

Device name
TOTIM Patient Cushion Immobilization System
Applicant
Essebi Medical Srl
Faetano, SM
Received
April 5, 2019
Decision date
April 30, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was TOTIM Patient Cushion Immobilization System cleared by the FDA?

TOTIM Patient Cushion Immobilization System (K190894) received a 510(k) decision of Substantially Equivalent on April 30, 2019, 25 days after the submission was received.

What is the product code of K190894?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.