Cleared Traditional

K883985 - CARDIAC CX

K883985 is the FDA 510(k) clearance for CARDIAC CX by Fischer Imaging Corp.. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K883985 · Fischer Imaging Corp. · Radiology device
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Nov 1988
Decision
62d
Days
Class 2
Risk

K883985 is an FDA 510(k) clearance for the CARDIAC CX. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on November 21, 1988 after a review of 62 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 Fischer Imaging Corp. devices

Submission Details

510(k) Number K883985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date November 21, 1988
Days to Decision 62 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
45d faster than avg
Panel avg: 107d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 135
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K883985.
DIGITAL SPOT IMAGING (DSI)
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K884317 · Medrad, Inc. · Dec 1988
CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM
K880527 · Fischer Imaging Corp. · Feb 1988
REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE
K874901 · Fischer Imaging Corp. · Jan 1988
LP LATERAL FLUORO POSITIONER (B5077A)
K872061 · General Electric Co. · Jun 1987