Ximaview(Tm)

FDA 510(k) K884323 · Varian Assoc., Inc.

Substantially Equivalent

510(k) numberK884323

Submission

Device name
Ximaview(Tm)
Applicant
Varian Assoc., Inc.
Palo Alto, CA, US
Received
October 14, 1988
Decision date
April 3, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Ximaview(Tm) cleared by the FDA?

Ximaview(Tm) (K884323) received a 510(k) decision of Substantially Equivalent on April 3, 1989, 171 days after the submission was received.

What is the product code of K884323?

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