Cleared Traditional

PHORMAX EAGLE SCANNER SYSTEM (K001499) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 142
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K001499.
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
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KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
K020635 · Eastman Kodak Company · Mar 2002
THORAX FD AND MULTIX FD
K983732 · Siemens Medical Solutions USA, Inc. · Apr 1999