Ingenuity TF

FDA 510(k) K172406 · Philips Medical Systems (Cleveland), Inc.

Substantially Equivalent

510(k) numberK172406

Submission

Device name
Ingenuity TF
Applicant
Philips Medical Systems (Cleveland), Inc.
Cleveland, OH, US
Received
August 9, 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
KPS – System, Tomography, Computed, Emission
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1200
Specialty
Radiology

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Questions and answers

When was Ingenuity TF cleared by the FDA?

Ingenuity TF (K172406) received a 510(k) decision of Substantially Equivalent on October 6, 2017, 58 days after the submission was received.

What is the product code of K172406?

The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.