(157 days)
Not Found
No
The summary describes a digital image recording and display system for various imaging modalities, focusing on image archiving and viewing. There is no mention of AI, ML, or related concepts in the provided text.
No
Explanation: The device is described as an image recording and display system for various digital imaging modalities, primarily for viewing and archiving medical images. Its intended use does not involve treating or diagnosing a disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The device is described as a "Digital image recording and display system" intended for viewing and archiving medical images. It does not perform analysis or interpretation of medical data to diagnose a condition.
No
The device description explicitly states it is a "Digital image recording and display system," which implies hardware components for recording and displaying images, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is for "on-line or remote viewing of cardiac catheterization angiography studies," "digital image archive," and use with "other digital imaging modalities." This describes a system for managing and displaying medical images, not for performing tests on biological samples to diagnose disease or other conditions.
- Device Description: The description reinforces this by calling it a "Digital image recording and display system."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is centered around the handling and display of medical images generated by other imaging modalities.
N/A
Intended Use / 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 interchage 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.
Product codes
Not Found
Device Description
Digital image recording and display system for use in cardiac catheterization, radiography/fluoroscopy, ultrasound, or other digital imaging modalities.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
cardiac catheterization angiography, R/F, nuclear, ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data: Not required for determination of substantial equivalence for this class of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Camironics Medical Systems. The logo features a stylized eye graphic to the left of the company name. The text "Camironics" is in a bold, sans-serif font, and below it, in smaller letters, is "MEDICAL SYSTEMS."
5519
510(k) Summary
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 interchage 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
Zoom
Window and level adjustment
Gamma correction | Edge enhancement
Zoom
Window and level adjustment
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.