Cleared Traditional

K896387 - SXT-60F/60M MOBILE C ARM X-RAY UNIT

K896387 is an FDA 510(k) clearance for SXT-60F/60M MOBILE C ARM X-RAY UNIT, manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K896387 · Toshiba America Medical Systems, In.C · Radiology device
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Feb 1990
Decision
109d
Days
Class 2
Risk

K896387 is an FDA 510(k) clearance for the SXT-60F/60M MOBILE C ARM X-RAY UNIT. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on February 23, 1990 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K896387

510(k) Number K896387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date February 23, 1990
Days to Decision 109 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
2d slower than avg
Panel avg: 107d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
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 - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 64
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K896387.
MOBILE X-RAY SYSTEM
K913525 · Siemens Medical Solutions USA, Inc. · Oct 1991
PHILIPS BV-29 IMAGING SYSTEM
K910115 · Philips Medical Systems, Inc. · Feb 1991
MODIFIED ALPHA MC-9R C-ARM
K900967 · Instrumentarium Imaging, Inc. · May 1990
MOBILE C-ARM OMNI 325
K880518 · Fischer Imaging Corp. · Mar 1988
FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.
K760429 · Varian Assoc., Inc. · Aug 1976