Cleared Special

K022565 - TELSTAR BIPLANE DIGITAL IMAGING SYSTEM ...

K022565 is an FDA 510(k) clearance for TELSTAR BIPLANE DIGITAL IMAGING SYSTEM ..., manufactured by Stereotaxis, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Special 510(k) pathway after a 67-day FDA review.

K022565 · Stereotaxis, Inc. · Radiology device
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Oct 2002
Decision
67d
Days
Class 2
Risk

K022565 is an FDA 510(k) clearance for the TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on October 8, 2002 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stereotaxis, Inc. devices

FDA 510(k) Submission Details - K022565

510(k) Number K022565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2002
Decision Date October 08, 2002
Days to Decision 67 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 107d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

JAA Device Classification - Class 2, Special Controls

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 143
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