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K Number
K052076
Device Name
DAR-8000I
Manufacturer
SHIMADZU MEDICAL SYSTEMS
Date Cleared
2005-09-02

(32 days)

Product Code
IZI
Regulation Number
892.1600
Type
Abbreviated
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is intended to be used for radiography in the hospital with X-ray devices.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device named DAR 8000i. This document does not contain information regarding:

  • Acceptance criteria for device performance
  • Details of a study proving the device meets acceptance criteria (including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

This letter primarily focuses on the FDA's "substantial equivalence" determination, regulatory classifications, and general compliance requirements, rather than a detailed performance study.

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.