Cleared Traditional

K001499 - PHORMAX EAGLE SCANNER SYSTEM

K001499 is an FDA 510(k) clearance for PHORMAX EAGLE SCANNER SYSTEM, manufactured by Phormax Corp.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K001499 · Phormax Corp. · Radiology device
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Dec 2000
Decision
226d
Days
Class 2
Risk

K001499 is an FDA 510(k) clearance for the PHORMAX EAGLE SCANNER SYSTEM. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Phormax Corp. (Los Altos, US). The FDA issued a Cleared decision on December 27, 2000 after a review of 226 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Phormax Corp. devices

FDA 510(k) Submission Details - K001499

510(k) Number K001499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2000
Decision Date December 27, 2000
Days to Decision 226 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 107d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 375
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K001499.
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ADC PEDIATRIC
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FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
K993861 · Fujifilm Medical System U.S.A., Inc. · Feb 2000
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K992794 · Infimed, Inc. · Nov 1999