SLS-CT

K960985 · Bio-Imaging Research, Inc. · JAK · Oct 25, 1996 · Radiology

Device Facts

• Record ID: K960985
• Device Name: SLS-CT
• Applicant: Bio-Imaging Research, Inc.
• Product Code: JAK · Radiology
• Decision Date: Oct 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The SLS-CT System manufactured by Bio-Imaging Research (BIR) is a passive add-on option to Philips Medical Systems, Inc.'s existing, legally marketed, Radiotherapy Simulators. The SLS-CT does not control the Simulator x-ray and mechanical functions. The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images. The SLS-CT is not a diagnostic tool.

Device Story

SLS-CT System; passive add-on for Philips Radiotherapy Simulators. Device gathers data from simulator; processes data into tomographic images. Does not control simulator x-ray or mechanical functions. Used in clinical radiotherapy settings by trained personnel. Output used for radiotherapy planning/simulation; not for diagnostic purposes. System verification/validation performed via Beta testing in clinical and manufacturer settings.

Clinical Evidence

Bench testing and two Beta tests performed; Beta Test 1 at Philips Medical Systems, Beta Test 2 in a clinical setting. In-house verification and validation conducted by BIR.

Technological Characteristics

Passive add-on hardware/software module. Complies with IEC601, UL 2601, CSA 601. Software developed per IEEE Software Engineering Standard. ISO9001 certified manufacturing.

Indications for Use

Indicated for use as a data gathering add-on for existing Philips Radiotherapy Simulators to enable tomographic image processing. Not for diagnostic use.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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OCT 28 1996

"SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION"

K960985

# for the BIO-IMAGING RESEARCH SLS-CT System 510(k) PREMARKET NOTIFICATION

"This 510(k) Summary of Safety and Effectiveness Information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990."


Donald Barham

Regulatory Affairs Manager

Bio-Imaging Research, Inc.

425 Barclay Blvd

Lincolnshire, IL 60069


The SLS-CT System manufactured by Bio-Imaging Research (BIR) is a passive add-on option to Philips Medical Systems, Inc.'s existing, legally marketed, Radiotherapy Simulators. The SLS-CT does not control the Simulator x-ray and mechanical functions. The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images. The SLS-CT is not a diagnostic tool.

The SLS-CT System complies with voluntary standards IEC601, UL 2601, and CSA 601. The SLS-CT software was developed utilizing the IEEE Software Engineering Standard as a model.

System and software requirements specifications were developed in concert with Philips Medical Systems. Modular testing of the hardware and software has been performed to the specifications. A hazard analysis of the hardware and software was performed by both Philips Medical Systems and BIR with safeguards instituted. Stringent software and hardware design and quality assurance procedures were adhered to. Stringent system verification and validation testing was performed per documented procedures during two Beta tests, with Beta Test 1 being performed at Philips Medical Systems and Beta Test 2 in a clinical setting. In-house verification and validation was performed by BIR. Operator, System Validation and Maintenance, and Service Manuals, along with Customer Acceptance Test Schedule documents provide the user with clear and concise information thus ensuring the safe and effective operation of the system.

BIR's manufacturing facility strictly adheres to and believes in the FDA's Good Manufacturing Practices. BIR's Quality System is certified to ISO9001 for the design, manufacturing, and service of medical imaging equipment.