Cleared Traditional

K810590 - P.R.M. 80

K810590 is an FDA 510(k) clearance for P.R.M. 80, manufactured by T.E.M. Instruments , Ltd.. The device is a Class 2 Radiology device with product code IZW cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K810590 · T.E.M. Instruments , Ltd. · Radiology device
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Apr 1981
Decision
37d
Days
Class 2
Risk

K810590 is an FDA 510(k) clearance for the P.R.M. 80. Classified as Collimator, Automatic, Radiographic (product code IZW), Class II - Special Controls.

Submitted by T.E.M. Instruments , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1981 after a review of 37 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 T.E.M. Instruments , Ltd. devices

FDA 510(k) Submission Details - K810590

510(k) Number K810590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1981
Decision Date April 10, 1981
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZW Device Classification - Class 2, Special Controls

Product Code IZW Collimator, Automatic, 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.