Cleared Traditional

K934700 - MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY

K934700 is an FDA 510(k) clearance for MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY, manufactured by Tempo Technology, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K934700 · Tempo Technology, Inc. · Radiology device
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Mar 1994
Decision
167d
Days
Class 2
Risk

K934700 is an FDA 510(k) clearance for the MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Tempo Technology, Inc. (Columbia City, US). The FDA issued a Cleared decision on March 16, 1994 after a review of 167 days - an extended review cycle.

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 Tempo Technology, Inc. devices

FDA 510(k) Submission Details - K934700

510(k) Number K934700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1993
Decision Date March 16, 1994
Days to Decision 167 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 107d · This submission: 167d
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 65
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K934700.
OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
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K953910 · Philips Medical Systems North America, Inc. · Oct 1995
SHIMADZU MOBILE X-RAY SYSTEMS
K940294 · Shimadzu Precision Instruments, Inc. · Mar 1994
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447 · GE Medical Systems · Aug 1993
COMET C-125
K914748 · Fischer Imaging Corp. · Oct 1992