Cleared Traditional

K981267 - FACTS MONOBLOCK

K981267 is an FDA 510(k) clearance for FACTS MONOBLOCK, manufactured by Dynarad Corp.. The device is a Class 2 Radiology device with product code IZX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K981267 · Dynarad Corp. · Radiology device
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May 1998
Decision
29d
Days
Class 2
Risk

K981267 is an FDA 510(k) clearance for the FACTS MONOBLOCK. Classified as Collimator, Manual, Radiographic (product code IZX), Class II - Special Controls.

Submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on May 6, 1998 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1610 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dynarad Corp. devices

FDA 510(k) Submission Details - K981267

510(k) Number K981267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1998
Decision Date May 06, 1998
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZX Device Classification - Class 2, Special Controls

Product Code IZX Collimator, Manual, Radiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
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 - IZX Collimator, Manual, Radiographic

All 7
Devices cleared under the same product code (IZX) and FDA review panel - the closest regulatory comparables to K981267.
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