Cleared Traditional

K882019 - SMS 90-15 R&F TABLE AND SMS 14 SPOT FIL...

K882019 is the FDA 510(k) clearance for SMS 90-15 R&F TABLE AND SMS 14 SPOT FIL... by General Electric Co.. It is a Class 2 Radiology device (product code IXR) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K882019 · General Electric Co. · Radiology device
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May 1988
Decision
18d
Days
Class 2
Risk

K882019 is an FDA 510(k) clearance for the SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on May 31, 1988 after a review of 18 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 General Electric Co. devices

Submission Details

510(k) Number K882019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1988
Decision Date May 31, 1988
Days to Decision 18 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
89d faster than avg
Panel avg: 107d · This submission: 18d
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 K882019.
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
K905153 · Shimadzu Medical Systems · Dec 1990
RMS 180
K893673 · Fischer Imaging Corp. · Jul 1989
GENESIS 180
K883863 · Fischer Imaging Corp. · Oct 1988
CEILING MOUNTED TILTING TABLE TANGENT III
K880529 · Fischer Imaging Corp. · Mar 1988
SIREGRAPH D
K860913 · Siemens Medical Solutions USA, Inc. · Apr 1986
TRIOSKOP
K792645 · Siemens Corp. · Jan 1980