Cleared Traditional

K910115 - PHILIPS BV-29 IMAGING SYSTEM

K910115 is the FDA 510(k) clearance for PHILIPS BV-29 IMAGING SYSTEM by Philips Medical Systems, Inc.. It is a Class 2 Radiology device (product code OXO) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K910115 · Philips Medical Systems, Inc. · Radiology device
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Feb 1991
Decision
41d
Days
Class 2
Risk

K910115 is an FDA 510(k) clearance for the PHILIPS BV-29 IMAGING SYSTEM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on February 20, 1991 after a review of 41 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.

View all Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K910115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1991
Decision Date February 20, 1991
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 32
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K910115.
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K880518 · Fischer Imaging Corp. · Mar 1988
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
K760429 · Varian Assoc., Inc. · Aug 1976