Cleared Traditional

K911739 - SWEMAC REISON BIPLANAR 300

K911739 is an FDA 510(k) clearance for SWEMAC REISON BIPLANAR 300, manufactured by Seemac Reison AB Co.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 189-day FDA review.

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

FDA 510(k) Submission Details - K911739

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.

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 66
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K911739.
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447 · GE Medical Systems · Aug 1993
COMET C-125
K914748 · Fischer Imaging Corp. · Oct 1992
PHILIPS BV26 MOBILE C-ARM STAND
K921255 · Philips Medical Systems, Inc. · May 1992
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