Fibre Interspaced X-ray grids used in diagnostic imaging to improve image quality by reducing scattered radiation. Device placed between patient and X-ray detector. Manufactured by Smit Roentgen; intended for use in clinical radiology environments. Operates as a passive component to filter X-ray beams.
Clinical Evidence
No clinical data provided; reliance on past experience with substantially equivalent devices and compliance with safety standards.
Technological Characteristics
Fibre interspaced X-ray grid; manufactured in accordance with IEC 627; subject to Federal Performance Standards (21CFR 1020.30/1020.31).
Regulatory Classification
Identification
A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.
Submission Summary (Full Text)
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smit röntgen
Postbox 218
5600 MD Eindhoven,
The Netherlands
Tel. 31.40.2762707 Fax. 31.40.2762478
smit röntgen
K963893
Department of Health and Human Services
Center for Devices and Radiological Health
Office of Device Evaluation
Premarket Notification section
NOV - 7 1996
Smit Roentgen Approbation
XB36150/96-09-26/RR/LS
XB 36150/RR/LS. 1996.09.26
# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
for
## SMIT ROENTGEN FIBRE INTERSPACED X-RAY GRIDS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990
The undersigned certifies that the 510(k) Premarket Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence
The information is summarized as follows:
1. The Fibre Interspaced X-ray grids are subject to Federal Performance Standards, defined in 21CFR- 982.1910
2. The Fibre Interspaced X-ray grids will be manufactured in accordance with voluntary safety standards, such as IEC publication 627
3. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when properly used.
Ing. R.W. Rijntjes
Approbation Manager Smit Roentgen
Eindhoven, The Netherlands
