Cleared Traditional

K883153 - UNDISTAT WITH EXPLORATOR 35 (UCS 35E)

K883153 is an FDA 510(k) clearance for UNDISTAT WITH EXPLORATOR 35 (UCS 35E), manufactured by Bay X-Ray, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K883153 · Bay X-Ray, Inc. · Radiology device
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Sep 1988
Decision
42d
Days
Class 2
Risk

K883153 is an FDA 510(k) clearance for the UNDISTAT WITH EXPLORATOR 35 (UCS 35E). Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Bay X-Ray, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on September 6, 1988 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 Bay X-Ray, Inc. devices

FDA 510(k) Submission Details - K883153

510(k) Number K883153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date September 06, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 K883153.
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
OMNI DIAGNOST
K874113 · Xre Corp. · Nov 1987