ArcCHECK-MR

FDA 510(k) K160057 · Sun Nuclear Corporation

Substantially Equivalent

510(k) numberK160057

Submission

Device name
ArcCHECK-MR
Applicant
Sun Nuclear Corporation
Melbourne, FL, US
Received
January 12, 2016
Decision date
May 13, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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 ArcCHECK-MR cleared by the FDA?

ArcCHECK-MR (K160057) received a 510(k) decision of Substantially Equivalent on May 13, 2016, 122 days after the submission was received.

What is the product code of K160057?

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