Search Results
Found 1 results
510(k) Data Aggregation
K Number
K083109Device Name
SUINSA DIAGNOSTIC X-RAY SYSTEM
Manufacturer
SUINSA
Date Cleared
2008-12-04
(45 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
SUINSA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suinsa Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Device Description
This system is a combination of the following Suinsa manufactured components:
The Hercules Generator, with models from 32 to 80 kW. .
The NOVA Ceiling Mounted Tube Stand .
. The NET4000 series X-ray table
The NBS2100 Bucky Wall Stand .
Ask a Question
Page 1 of 1