Cleared Traditional

K921516 - P2900 X-RAY GENERATOR

K921516 is an FDA 510(k) clearance for P2900 X-RAY GENERATOR, manufactured by Precise Optics Photo Medic Equipment, Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K921516 · Precise Optics Photo Medic Equipment, Inc. · Radiology device
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May 1992
Decision
58d
Days
Class 1
Risk

K921516 is an FDA 510(k) clearance for the P2900 X-RAY GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Precise Optics Photo Medic Equipment, Inc. (Bay Shore, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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 Precise Optics Photo Medic Equipment, Inc. devices

FDA 510(k) Submission Details - K921516

510(k) Number K921516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date May 28, 1992
Days to Decision 58 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

IZO Device Classification - Class 1, General Controls

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IZO Generator, High-voltage, X-ray, Diagnostic

All 100
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K921516.
POLYDOROS XS50 AND SX80
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