SELECT/SP

K961464 · Elscint, Inc. · JAK · Jul 3, 1996 · Radiology

Device Facts

• Record ID: K961464
• Device Name: SELECT/SP
• Applicant: Elscint, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jul 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Device Story

SeleCT/SP is a spiral CT scanner; compact design; real-time image processing. Device acquires X-ray data via gantry rotation; transforms data into cross-sectional images. Used in clinical settings by radiology staff. Output viewed by physicians for diagnostic imaging. Benefits include cost-effective spiral scanning capabilities.

Clinical Evidence

Bench testing only; no clinical data provided. Safety and effectiveness established via comparison of technical specifications and standards compliance (IEC601-1) against predicate devices.

Technological Characteristics

Spiral CT scanner; compact gantry; Class I laser localizer system. Complies with IEC601-1 safety standard. Real-time image processing capabilities.

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.

Predicate Devices

• HeliCAT (K930090)

Reference Devices

• Exel 905 GT (K884667)
• AngioCT (K932508/B)
• ProVision by Algotec Ltd. (K954678)

Submission Summary (Full Text)

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K961464

# Summary of Safety and Effectiveness

JUL - 3 1996

## 1. Device Name

SeleCT/SP

## 2. Submitter

Elscint Inc.,
505 Main Str.
Hackensack, NJ 07601.

## 3. Description of Main Features

The SeleCT/SP is a cost effective spiral scanner, with compact siting requirements and real-time image processing functions.

## 4. Predicate Devices

- HeliCAT, K930090.
- Other related devices:
- Exel 905 GT, K884667
- AngioCT, K932508/B
- ProVision by Algotec Ltd., Raanana, Israel, K954678

## 5. Safety

The SeleCT/SP complies with IEC601-1 safety standard. Its safety is not significantly different from the predicate device. HeliCAT.

Its scan modes and radiation doses are similar those of the predicate device.

The laser localizer system is Class I and does not therefore significantly change the safety of the device.

## 6. Effectiveness

The effectiveness of SeleCT/SP is not significantly changed in respect to the predicate device, HeliCAT: the longer scan time and smaller gantry aperture affect the convenience of use; the lower spatial resolution and X-ray power are similar to those of Exel 905 GT.

## 7. Substantial Equivalency Statement

Based on the above considerations, it is Elscint’s opinion that the SeleCT/SP CT scanner is substantially equivalent in safety and effectiveness to the predicate device, HeliCAT, K930090.