Cleared Traditional

K905501 - ELITE 5000

K905501 is the FDA 510(k) clearance for ELITE 5000 by Fischer Imaging Corp.. It is a Class 2 Radiology device (product code IXR) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K905501 · Fischer Imaging Corp. · Radiology device
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Jan 1991
Decision
42d
Days
Class 2
Risk

K905501 is an FDA 510(k) clearance for the ELITE 5000. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Addison, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 42 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 Fischer Imaging Corp. devices

Submission Details

510(k) Number K905501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date January 18, 1991
Days to Decision 42 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
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXR Table, Radiographic, Tilting
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 - IXR Table, Radiographic, Tilting

All 33
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K905501.
PHILIPS URO DIAGNOST MRF
K911098 · Philips Medical Systems, Inc. · Jul 1991
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004
K911267 · Tri W-G, Inc. · Apr 1991
620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
K905265 · Tri W-G, Inc. · Jan 1991
REMOTE CONTROLLED X-RAY DIAG. RSZ-200
K905152 · Shimadzu Medical Systems · Dec 1990
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
K905153 · Shimadzu Medical Systems · Dec 1990
RMS 180
K893673 · Fischer Imaging Corp. · Jul 1989