Cleared Traditional

EP-X BIPLANE (K961207) - FDA 510(k) Clearance

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

K961207 · Fischer Imaging Corp. · Radiology device
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Aug 1996
Decision
146d
Days
Class 2
Risk

K961207 is an FDA 510(k) clearance for the EP-X BIPLANE. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on August 20, 1996 after a review of 146 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 Fischer Imaging Corp. devices

Submission Details

510(k) Number K961207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1996
Decision Date August 20, 1996
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 107d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 59
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K961207.
EXPEDIO 500D R&F X-RAY SYSTEM
K011624 · GE Medical Systems · Jun 2001
CAREGRAPH
K982319 · Siemens Medical Solutions USA, Inc. · Sep 1998
FLUOROSPOT COMPACT
K982028 · Siemens Medical Solutions USA, Inc. · Jul 1998
SIREGRAPH CF
K960266 · Siemens Medical Solutions USA, Inc. · Mar 1996
SIRESKOP SX
K951358 · Siemens Medical Solutions USA, Inc. · May 1995
NRF SYSTEM
K944973 · Philips Medical Systems (Cleveland), Inc. · Dec 1994