FIBRE INTERSPACED X-RAY GRID

K963893 · Smit Rontgen · IXJ · Nov 7, 1996 · Radiology

Device Facts

• Record ID: K963893
• Device Name: FIBRE INTERSPACED X-RAY GRID
• Applicant: Smit Rontgen
• Product Code: IXJ · Radiology
• Decision Date: Nov 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1910
• Device Class: Class 1

Device Story

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. [phone] Fax. [phone]
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