Who is the manufacturer of RPS-50 BEAM SCANNER?

Sofield Science Services, Inc. submitted the Traditional clearance for RPS-50 BEAM SCANNER (K962080).

What is the FDA product code for RPS-50 BEAM SCANNER?

IYE. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for RPS-50 BEAM SCANNER?

510(k) clearance (submission type: Traditional).

RPS-50 BEAM SCANNER

K962080 · Sofield Science Services, Inc. · IYE · Aug 23, 1996 · Radiology

Device Facts

Record ID	K962080
Device Name	RPS-50 BEAM SCANNER
Applicant	Sofield Science Services, Inc.
Product Code	IYE · Radiology
Decision Date	Aug 23, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2

Intended Use

The RPS-50 is intended to be used as an accessory to a linear accelerator under the direct control of a qualified individual (usually a therapeutic radiation physicist.) The scanner may be used for acceptance testing of new accelerators, quality control of existing accelerators, or for the collection of data necessary for the operation of a computerized treatment planning system.

Device Story

RPS-50 Beam Scanner; accessory to clinical linear accelerator. System components: water tank, linear scanning guides, electronic movement control, chamber bias, system gain control. Operation: software-controlled movement of radiation detector through high radiation field; data collection; output as computer screen plots, data tables, or floppy disk files. Usage: clinical setting; operated by therapeutic radiation physicist. Output utility: data used for accelerator quality control and treatment planning system input; assists physicist in verifying radiation beam characteristics.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Water tank, linear scanning guides, electronic movement control, chamber bias, system gain control. Software-controlled signal acquisition. Output formats: screen plot, data table, floppy disk.

Indications for Use

Indicated for use by therapeutic radiation physicists for acceptance testing and quality control of clinical linear accelerators, and for collecting radiation beam data for computerized treatment planning systems.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

A.R.M. beam scanner (K933558)

Related Devices

K161807 — BEAMSCAN · Ptw-Freiburg Physikalisch Technische-Werksraetten · May 19, 2017
K200907 — Thales 3D Mr Scanner · Lap GmbH Laser Applikationen · Jun 3, 2020
K961400 — RFA-300, LDA UTILITY · Scanditronix Medical AB · Jan 3, 1997
K191646 — Beamscan MR · Ptw-Freiburg Physikalisch-Technische-Werkstaetten · Feb 21, 2020
K101992 — 3D SCANNER, MODEL 1230 · Sun Nuclear Corp. · Oct 1, 2010

Submission Summary (Full Text)

{0} A8 23 1988 TAB 12. K962080 # PREMARKET NOTIFICATION [510(k)] SUMMARY **Trade Name:** RPS-50 Beam Scanner **Common Name:** Beam scanner for clinical linear accelerator **Classification Name and Number:** None given **Class:** Class II, accessory to a linear accelerator **Predicate:** A.R.M. beam scanner; control number K933558 **Description:** The RPS-50 scanner consists of a water tank, linear scanning guides, electronic control of movement, chamber bias, and system gain control. A software program controls all movements and necessary electronic signals. The scanner moves a radiation detector through a field of high radiation and presents the collected data as a plot on a computer screen, as a table of data or on a floppy disk suitable for use in a treatment planning system. **Intended Use:** The RPS-50 is intended to be used as an accessory to a linear accelerator under the direct control of a qualified individual (usually a therapeutic radiation physicist.) The scanner may be used for acceptance testing of new accelerators, quality control of existing accelerators, or for the collection of data necessary for the operation of a computerized treatment planning system. **Technological Characteristics:** The technological characteristics of the RPS-50 scanner and the predicate device are the same in that both are meant to collect beam data descriptive of the accelerator scanned. The data for both devices is evaluated by a clinical physicist for completeness and accuracy. **Prepared by:** Jack C. Sofield, President Sofield Science Services, Inc. Seymour, TN 37865-5017 Tel. 423 573 1795; Fax. 423 577 8713 Date: May 21, 1996