Aquilion Prime SP, TSX-303B/1, v8.4

FDA 510(k) K172188 · Toshiba Medical Systems Coroporation

Substantially Equivalent

510(k) numberK172188

Submission

Device name
Aquilion Prime SP, TSX-303B/1, v8.4
Applicant
Toshiba Medical Systems Coroporation
Otawara-Shi, JP
Received
July 20, 2017
Decision date
October 6, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAK – System, X-Ray, Tomography, Computed
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

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Questions and answers

When was Aquilion Prime SP, TSX-303B/1, v8.4 cleared by the FDA?

Aquilion Prime SP, TSX-303B/1, v8.4 (K172188) received a 510(k) decision of Substantially Equivalent on October 6, 2017, 78 days after the submission was received.

What is the product code of K172188?

The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.