Cleared Traditional

MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY (K934700) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 23
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K934700.
ACCENT 16, ACCENT 22
K980322 · GE Medical Systems · Apr 1998
SIREMOBIL CO2
K973598 · Siemens Medical Solutions USA, Inc. · Nov 1997
SIREMOBIL COMPACT
K963093 · Siemens Medical Solutions USA, Inc. · Sep 1996
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447 · GE Medical Systems · Aug 1993
MOBILE X-RAY SYSTEM
K913525 · Siemens Medical Solutions USA, Inc. · Oct 1991
SXT-60F/60M MOBILE C ARM X-RAY UNIT
K896387 · Toshiba America Medical Systems, In.C · Feb 1990