Cleared Traditional

K961690 - CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105

K961690 is an FDA 510(k) clearance for CARDIOARC SERIES: POSITIONER C-ARM MODE..., manufactured by Continental X-Ray Corp.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K961690 · Continental X-Ray Corp. · Radiology device
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Jun 1996
Decision
57d
Days
Class 2
Risk

K961690 is an FDA 510(k) clearance for the CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on June 27, 1996 after a review of 57 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 Continental X-Ray Corp. devices

FDA 510(k) Submission Details - K961690

510(k) Number K961690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1996
Decision Date June 27, 1996
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 189
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K961690.
EP-X BIPLANE
K961207 · Fischer Imaging Corp. · Aug 1996
TOPOGRAPHIC IMAGING MARKER
K962606 · I.Z.I. Medical Products Corp. · Aug 1996
ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300
K962140 · Continental X-Ray Corp. · Jul 1996
FULL FRAME ZOOM SYSTEM
K961193 · Xre Corp. · Jun 1996
RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
K955687 · Contour Fabricators of Florida, Inc. · Jun 1996
SBDX MOBILE FLUOROSCOPY SYSTEM
K953113 · Cardiac Mariners, Inc. · Mar 1996