Cleared Traditional

K233678 - Radiography 7000 M

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

K233678 · Philips Medical Systems Dmc GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K233678

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.

IZL Device Classification - Class 2, Special Controls

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 172
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K233678.
ERI Portable X-ray System (CVX-air)
K234108 · Energy Resources International Co., Ltd. · Sep 2024
iQFlex Pro
K240009 · First Source, Inc. · Jul 2024
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)
K240284 · Shenzhen Browiner Tech Co., Ltd. · Mar 2024
SM-IV
K232185 · Sedecal., Sa. · Aug 2023
TOPA12 Portable X-ray Unit
K230581 · Neuf, Inc. · Aug 2023
MOBILETT Impact
K231577 · Siemens Medical Solutions · Jul 2023