Allura Xper or Table Series

FDA 510(k) K102005 · Philips Medical Systems North America, Inc.

Substantially Equivalent

510(k) numberK102005

Submission

Device name
Allura Xper or Table Series
Applicant
Philips Medical Systems North America, Inc.
Bothell, WA, US
Received
July 15, 2010
Decision date
August 9, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
OWB – Interventional Fluoroscopic X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Interventional fluoroscopy

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K252229Belliger AceOWB · Traditional Genoray Co., Ltd.04/02/2026SE

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Questions and answers

When was Allura Xper or Table Series cleared by the FDA?

Allura Xper or Table Series (K102005) received a 510(k) decision of Substantially Equivalent on August 9, 2010, 25 days after the submission was received.

What is the product code of K102005?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.