XKNIFE-4

FDA 510(k) K981055 · Radionics, Inc.

Substantially Equivalent

510(k) numberK981055

Submission

Device name
XKNIFE-4
Applicant
Radionics, Inc.
Burlington, MA, US
Received
March 23, 1998
Decision date
September 29, 1998
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 XKNIFE-4 cleared by the FDA?

XKNIFE-4 (K981055) received a 510(k) decision of Substantially Equivalent on September 29, 1998, 190 days after the submission was received.

What is the product code of K981055?

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