Cleared Traditional

K052473 - CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000

K052473 is an FDA 510(k) clearance for CX 250 C PLUS WITH GAMMAXP SOFTWARE, manufactured by Inter Medical Medizintechnik GmbH. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K052473 · Inter Medical Medizintechnik GmbH · Radiology device
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Oct 2005
Decision
49d
Days
Class 1
Risk

K052473 is an FDA 510(k) clearance for the CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Inter Medical Medizintechnik GmbH (Luebbecke, DE). The FDA issued a Cleared decision on October 28, 2005 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Inter Medical Medizintechnik GmbH devices

FDA 510(k) Submission Details - K052473

510(k) Number K052473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2005
Decision Date October 28, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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