Raycast High Precision Lung Board Solution

Q: What is the product code of K162862?

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

FDA 510(k) K162862 · Orfit Industries NV

Substantially Equivalent

510(k) numberK162862

Submission

Device name: Raycast High Precision Lung Board Solution
Applicant: Orfit Industries NV
Wijnegem, BE
Received: October 12, 2016
Decision date: November 9, 2016
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 Raycast High Precision Lung Board Solution cleared by the FDA?

Raycast High Precision Lung Board Solution (K162862) received a 510(k) decision of Substantially Equivalent on November 9, 2016, 28 days after the submission was received.

What is the product code of K162862?

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