Somavision

FDA 510(k) K992751 · Varian Assoc., Inc.

Substantially Equivalent

510(k) numberK992751

Submission

Device name
Somavision
Applicant
Varian Assoc., Inc.
Palo Alto, CA, US
Received
August 16, 1999
Decision date
February 16, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPQ – System, Simulation, Radiation Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5840
Specialty
Radiology

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Questions and answers

When was Somavision cleared by the FDA?

Somavision (K992751) received a 510(k) decision of Substantially Equivalent on February 16, 2000, 184 days after the submission was received.

What is the product code of K992751?

The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.