Cleared Traditional

K884531 - BETA 90/50 MOBILE IMAGING TABLE

K884531 is an FDA 510(k) clearance for BETA 90/50 MOBILE IMAGING TABLE, manufactured by Beta Medical Products Co.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K884531 · Beta Medical Products Co. · Radiology device
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Jan 1989
Decision
75d
Days
Class 2
Risk

K884531 is an FDA 510(k) clearance for the BETA 90/50 MOBILE IMAGING TABLE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Beta Medical Products Co. (Akron, US). The FDA issued a Cleared decision on January 11, 1989 after a review of 75 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 Beta Medical Products Co. devices

FDA 510(k) Submission Details - K884531

510(k) Number K884531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1988
Decision Date January 11, 1989
Days to Decision 75 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 107d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXR Device Classification - Class 2, Special Controls

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 49
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K884531.
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
K905153 · Shimadzu Medical Systems · Dec 1990
RMS 180
K893673 · Fischer Imaging Corp. · Jul 1989
TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE
K892226 · Tecnomed, Inc. · Apr 1989
GENESIS 180
K883863 · Fischer Imaging Corp. · Oct 1988
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
K882019 · General Electric Co. · May 1988
CEILING MOUNTED TILTING TABLE TANGENT III
K880529 · Fischer Imaging Corp. · Mar 1988