Cleared Traditional

K233678 - Radiography 7000 M

K233678 is the FDA 510(k) clearance for Radiography 7000 M by Philips Medical Systems Dmc GmbH. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K233678 · Philips Medical Systems Dmc GmbH · Radiology device
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Feb 2024
Decision
90d
Days
Class 2
Risk

K233678 is an FDA 510(k) clearance for the Radiography 7000 M. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Philips Medical Systems Dmc GmbH (Hamburg, DE). The FDA issued a Cleared decision on February 14, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Philips Medical Systems Dmc GmbH devices

Submission Details

510(k) Number K233678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2023
Decision Date February 14, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 116
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K233678.
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