Cleared Traditional

K940696 - SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5

K940696 is the FDA 510(k) clearance for SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 by Philips Medical Systems North America, Inc.. It is a Class 2 Radiology device (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

Submission Details

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.

Device Classification

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 10
Devices cleared under the same product code (KXJ) and FDA review panel - the closest regulatory comparables to K940696.
CARBON FIBER COUCH INSERT
K950068 · Medtec, Inc. · Apr 1995
CAG-02A
K922098 · Toshiba America Medical Systems, In.C · Jul 1992
OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
K871827 · General Electric Co. · Jun 1987
SHAMPAINE RADI-OP MODEL 1700RC
K860620 · Smith & Nephew, Inc. · Apr 1986
MEDEX X-RAY TABLE
K854328 · Philips Medical Systems (Cleveland), Inc. · Jan 1986
SIEMENS SIRESKOP 4
K820111 · Siemens Corp. · Feb 1982