Cleared Traditional

X-CELL X-RAY #'S P-75W/P-75M (K811230) - FDA 510(k) Clearance

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

K811230 · X-Cel X-Ray Corp. · Radiology device
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Jun 1981
Decision
50d
Days
Class 2
Risk

K811230 is an FDA 510(k) clearance for the X-CELL X-RAY #'S P-75W/P-75M. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by X-Cel X-Ray Corp. (Mchenry, US). The FDA issued a Cleared decision on June 23, 1981 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 X-Cel X-Ray Corp. devices

Submission Details

510(k) Number K811230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date June 23, 1981
Days to Decision 50 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 107d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 117
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K811230.
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