Hitachi Versiflex

FDA 510(k) K991231 · Hitachi Medical Systems America, Inc.

Substantially Equivalent

510(k) numberK991231

Submission

Device name
Hitachi Versiflex
Applicant
Hitachi Medical Systems America, Inc.
Rockville, MD, US
Received
April 12, 1999
Decision date
May 24, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZI – System, X-Ray, Angiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1600
Specialty
Radiology

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Questions and answers

When was Hitachi Versiflex cleared by the FDA?

Hitachi Versiflex (K991231) received a 510(k) decision of Substantially Equivalent on May 24, 1999, 42 days after the submission was received.

What is the product code of K991231?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.