Cleared Traditional

K931071 - PHILIPS THORAVISION

K931071 is the FDA 510(k) clearance for PHILIPS THORAVISION by Philips Medical Systems, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 562-day FDA review.

K931071 · Philips Medical Systems, Inc. · Radiology device
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Sep 1994
Decision
562d
Days
Class 2
Risk

K931071 is an FDA 510(k) clearance for the PHILIPS THORAVISION. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on September 15, 1994 after a review of 562 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K931071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1993
Decision Date September 15, 1994
Days to Decision 562 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
455d slower than avg
Panel avg: 107d · This submission: 562d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K931071.
UNIVERSIX 120
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K941931 · Victoreen, Inc. · May 1994
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K934005 · Shimadzu Corp. · Nov 1993