← Product Code [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI) · K955519 # ANALYTICAL REVIEW STATION (K955519) _Camtronics, Ltd. · IZI · May 9, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K955519 ## Device Facts - **Applicant:** Camtronics, Ltd. - **Product Code:** [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI.md) - **Decision Date:** May 9, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1600 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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. ## Regulatory 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](/device/K941979.md)) - Camtronics Ltd. Archium ([K934496](/device/K934496.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: 414-367-0717 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K955519](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K955519) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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