Cleared Traditional

K130842 - ALLURA XPER FD OR TABLE SERIES

Also marketed or referenced as:
ALLURA XPER FD10 SERIES ALLURA XPER FD20 SERIES ALLURA XPER FD BIPLANE SERIES

K130842 is the FDA 510(k) clearance for ALLURA XPER FD OR TABLE SERIES by Philips Medical Systems Nederland B.V.. It is a Class 2 Radiology device (product code IZI) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K130842 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
55d
Days
Class 2
Risk

K130842 is an FDA 510(k) clearance for the ALLURA XPER FD OR TABLE SERIES. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on May 21, 2013 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Medical Systems Nederland B.V. devices

Submission Details

510(k) Number K130842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2013
Decision Date May 21, 2013
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Dekra Certification B.V
J.A. VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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