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510(k) Data Aggregation
K Number
K043062Device Name
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEMManufacturer
Date Cleared
2004-12-13
(38 days)
Product Code
Regulation Number
892.1720Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Model SR-130-D Digital Portable X-Ray System is The Model OR Too E Portable Radiographic Applications.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter for a Portable Digital X-Ray System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter primarily:
- Confirms the FDA's review of the premarket notification.
- States that the device is substantially equivalent to legally marketed predicate devices.
- Outlines general regulatory requirements for the manufacturer.
- Provides contact information for further inquiries.
- Includes the "Indications For Use" statement.
Therefore, I cannot provide the requested information based on the input text.
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