Cleared Traditional

K070528 - PHILIPS ESSENTA DR

K070528 is an FDA 510(k) clearance for PHILIPS ESSENTA DR, manufactured by Philips Medical Systems GmbH, Dmc. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K070528 · Philips Medical Systems GmbH, Dmc · Radiology device
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Mar 2007
Decision
14d
Days
Class 2
Risk

K070528 is an FDA 510(k) clearance for the PHILIPS ESSENTA DR. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Philips Medical Systems GmbH, Dmc (Bothell, US). The FDA issued a Cleared decision on March 9, 2007 after a review of 14 days - a notably fast clearance 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: 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 Philips Medical Systems GmbH, Dmc devices

FDA 510(k) Submission Details - K070528

510(k) Number K070528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2007
Decision Date March 09, 2007
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 300
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