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XperCT Rel. 3

by Philips Medical Systems Nederland B.V.

510(k) K130893

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK130893 Date6 Sep 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

XperCT Rel. 3 is a software medical device for angiography labs that transforms rotational fluoroscopic x-ray acquisitions into 3D cross-sectional volumes. It includes image reconstruction filters to reduce noise from metal or high-radiation-absorbing objects.

The device is manufactured by Philips Medical Systems Nederland B.V. and received FDA 510(k) clearance as substantially equivalent on September 6, 2013. It is classified as an Interventional Fluoroscopic X-ray System with product code OWB and regulation number 892.1650. The device is intended for use in radiology settings.

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is XperCT Rel. 3 used for in medical imaging?

    XperCT Rel. 3 is a software medical device designed for angiography labs that converts rotational fluoroscopic x-ray acquisitions into 3D cross-sectional volumes, featuring image reconstruction filters to reduce noise from metal or high-radiation-absorbing objects.

  • How is XperCT Rel. 3 supplied and what are its storage requirements?

    The device is supplied as software for installation on compatible angiography systems. Storage requirements would follow standard software protocols for medical devices, though specific details aren't provided in the available documentation.

  • What regulatory approvals has XperCT Rel. 3 received?

    XperCT Rel. 3 received FDA 510(k) clearance as substantially equivalent on September 6, 2013. It is classified as an Interventional Fluoroscopic X-ray System with product code OWB and regulation number 892.1650, intended for use in radiology settings.

  • Can XperCT Rel. 3 be used with different angiography systems?

    The device is compatible with various angiography systems manufactured by Philips, as evidenced by the multiple FEI numbers listed in the FDA documentation, though specific compatibility details would need to be confirmed with the manufacturer.