Cleared Traditional

K940696 - SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5

K940696 is an FDA 510(k) clearance for SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5, manufactured by Philips Medical Systems North America, Inc.. The device is a Class 2 Radiology device with product code KXJ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K940696 · Philips Medical Systems North America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
28d
Days
Class 2
Risk

K940696 is an FDA 510(k) clearance for the SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on March 16, 1994 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 North America, Inc. devices

FDA 510(k) Submission Details - K940696

510(k) Number K940696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1994
Decision Date March 16, 1994
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXJ Device Classification - Class 2, Special Controls

Product Code KXJ Table, Radiologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - KXJ Table, Radiologic

All 17
Devices cleared under the same product code (KXJ) and FDA review panel - the closest regulatory comparables to K940696.
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K913121 · Continental X-Ray Corp. · Aug 1991