Cleared Traditional

K811082 - BETA I & BETA II

K811082 is an FDA 510(k) clearance for BETA I & BETA II, manufactured by Porta Ray, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K811082 · Porta Ray, Inc. · Radiology device
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May 1981
Decision
30d
Days
Class 2
Risk

K811082 is an FDA 510(k) clearance for the BETA I & BETA II. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Porta Ray, Inc. (Walker, US). The FDA issued a Cleared decision on May 21, 1981 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Porta Ray, Inc. devices

FDA 510(k) Submission Details - K811082

510(k) Number K811082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date May 21, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 184
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K811082.
MODEL MBA-130 MOBILE X-RAY SYSTEM
K862118 · Elscint, Inc. · Jun 1986
APR MOBILE
K843192 · Philips Medical Systems (Cleveland), Inc. · Sep 1984
PMX MOBILE X-RAY SYSTEM
K833226 · Philips Medical Systems, Inc. · Oct 1983
TECHNY REX 3000 MOBILE X-RAY UNIT
K803103 · Tecnomed, Inc. · Jan 1981
AMX-III
K802047 · General Electric Co. · Oct 1980
MOBIL XR
K781705 · Siemens Corp. · Oct 1978