Cleared Traditional

K010762 - PHILIPS BV LIBRA

K010762 is an FDA 510(k) clearance for PHILIPS BV LIBRA, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K010762 · Philips Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
19d
Days
Class 2
Risk

K010762 is an FDA 510(k) clearance for the PHILIPS BV LIBRA. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Da Best, NL). The FDA issued a Cleared decision on April 2, 2001 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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.

FDA 510(k) Submission Details - K010762

510(k) Number K010762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2001
Decision Date April 02, 2001
Days to Decision 19 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
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 Peers - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 81
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K010762 · PHILIPS BV LIBRA
Download PDF FDA Summary Philips Medical Syste…