ANALYTICAL REVIEW STATION

K955519 · Camtronics, Ltd. · IZI · May 9, 1996 · Radiology

Device Facts

• Record ID: K955519
• Device Name: ANALYTICAL REVIEW STATION
• Applicant: Camtronics, Ltd.
• Product Code: IZI · Radiology
• Decision Date: May 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Indications for Use

This product is intended primarily for on-line or remote viewing of cardiac catheterization angiography studies communicated by network, or transported by CD-R interchange media. The CD-R media may also be used as a full resolution digital image archive of complete cath lab studies, to replace cine film. The ARS2 can optionally be used with other digital imaging modalities, such as R/F, nuclear and ultrasound. The ARS2 provides the capability to write and read CD-R optical discs which are produced in accordance with the ACC/NEMA DICOM standard.

Device Story

Digital image recording/display system; inputs include cardiac catheterization, R/F, nuclear, and ultrasound images via network or CD-R media. Operates as workstation for viewing, archiving, and quantitative analysis of studies. Features include edge enhancement, zoom, window/level adjustment, gamma correction, and subtraction. Quantitative analysis includes ventricular wall motion/volume and arteriogram analysis. Used in clinical settings by medical professionals to replace cine film; facilitates diagnostic review and clinical decision-making through high-resolution digital display and standardized DICOM data interchange.

Clinical Evidence

No clinical data provided; performance data not required for determination of substantial equivalence for this class of device.

Technological Characteristics

Digital imaging workstation; supports 8-bit grayscale, 1024x1024 display matrix, 1280x1024 video output. Storage via hard disk and CD-R. Connectivity via network and DICOM-compliant optical media. Image processing includes edge enhancement, zoom, window/level, gamma correction, and subtraction. Quantitative analysis modules for ventricular and arteriogram assessment.

Indications for Use

Indicated for clinicians requiring on-line or remote viewing and archiving of digital medical images, including cardiac catheterization angiography, radiography/fluoroscopy, nuclear medicine, and ultrasound studies.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Camtronics Ltd. Video Plus (K941979)
• Camtronics Ltd. Archium (K934496)

Submission Summary (Full Text)

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Camtronics MEDICAL SYSTEMS
5519
K955519
MAY - 9 1996

Date prepared: November 22, 1995

Name of contact person: Robert Kriedermann

Device trade name: Analytical Review Station (ARS2, subject to change)

Common name: Digital Imaging Workstation

Classification name: Medical Image Picture Archiving and Communications Device

Predicate substantially equivalent devices: Camtronics Ltd. "Video Plus" (K941979), Camtronics Ltd. "Archium" (K934496)

Device description: Digital image recording and display system for use in cardiac catheterization, radiography/fluoroscopy, ultrasound, or other digital imaging modalities.

Intended use: This product is intended primarily for on-line or remote viewing of cardiac catheterization angiography studies communicated by network, or transported by CD-R interchange media. The CD-R media may also be used as a full resolution digital image archive of complete cath lab studies, to replace cine film. The ARS2 can optionally be used with other digital imaging modalities, such as R/F, nuclear and ultrasound. The ARS2 provides the capability to write and read CD-R optical discs which are produced in accordance with the ACC/NEMA DICOM standard.

Predicate device specifications comparison:

| | Camtronics Analytical Review Station | Camtronics Analytical Workstation K941979 |
| --- | --- | --- |
| Image Storage and Display | | |
| Gray scale resolution | 8 bit, 256 levels | 8 bit, 256 levels |
| Stored image matrix size | 512 x 512, 1024 x 512, or 1024 x 1024 | 512 x 512, 1024 x 512, or 1024 x 1024 |
| Displayed image matrix size | 1024 x 1024 | 1024 x 1024 |
| Display video output | 1280 x 1024, 72 hz refresh, color or monochrome; progressive | 1280 x 1024, 72 hz refresh, color, progressive |
| Screen size | 16 in., 19 in., or 20 in. | 16 in., 19 in., or 20 in. |
| Image formats | DICOM, Siemens, GE, Philips, Picker, others; 1, 4, or 16 on 1 | Siemens, GE, Philips, Picker, others; 1, 4, or 16 on 1 |
| Media | Hard disk, CD-R | Hard disk, CD-R |
| Compression | JPEG Processes 1 and 14, dual-track lossy or lossless | JPEG Process 14, lossless |
| Image Processing Functions | Edge enhancement | Edge enhancement |
| | Zoom | Zoom |
| | Window and level adjustment | Window and level adjustment |
| | Gamma correction | Gamma correction |
| | Subtraction | Subtraction |
| Quantitative Analysis | | |
| Ventricular Analysis | Sheehan/Dodge centerline algorithm for regional wall motion analysis, and LV volume computation; others | Sheehan/Dodge centerline algorithm for regional wall motion analysis, and LV volume computation. |
| Arteriogram Analysis | Saunders Data Systems, others | Artrek by QCS, Inc. |

Performance data: Not required for determination of substantial equivalence for this class of device.

Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.

Camtronics Ltd., A Subsidiary of ANALOGIC Corporation
900 Walnut Ridge Drive • P.O. Box 950 • Hartland, WI 53029 • 414-367-0700 • Fax: [phone]