Cleared Traditional

SWEMAC REISON BIPLANAR 300 (K911739) - FDA 510(k) Clearance

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

K911739 · Seemac Reison AB Co. · Radiology device
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Oct 1991
Decision
189d
Days
Class 2
Risk

K911739 is an FDA 510(k) clearance for the SWEMAC REISON BIPLANAR 300. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Seemac Reison AB Co. (Sweden, SE). The FDA issued a Cleared decision on October 23, 1991 after a review of 189 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 Seemac Reison AB Co. devices

Submission Details

510(k) Number K911739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date October 23, 1991
Days to Decision 189 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 107d · This submission: 189d
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 K911739.
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