Cleared Traditional

K910503 - DISCOGRAPHY KIT

K910503 is an FDA 510(k) clearance for DISCOGRAPHY KIT, manufactured by B. Braun of America, Inc.. The device is a Class 2 Radiology device with product code IZG cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K910503 · B. Braun of America, Inc. · Radiology device
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Oct 1991
Decision
244d
Days
Class 2
Risk

K910503 is an FDA 510(k) clearance for the DISCOGRAPHY KIT. Classified as System, X-ray, Photofluorographic (product code IZG), Class II - Special Controls.

Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 7, 1991 after a review of 244 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1730 - 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 B. Braun of America, Inc. devices

FDA 510(k) Submission Details - K910503

510(k) Number K910503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 05, 1991
Decision Date October 07, 1991
Days to Decision 244 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 107d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZG Device Classification - Class 2, Special Controls

Product Code IZG System, X-ray, Photofluorographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1730
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.