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K Number
K043062
Device Name
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
Manufacturer
SOURCE-RAY, INC.
Date Cleared
2004-12-13

(38 days)

Product Code
IZL
Regulation Number
892.1720
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
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.

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.