(196 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard digital image recording and display functions.
No
The device is described as an "image recording and display system," which suggests a diagnostic rather than a therapeutic function.
No
The device is described as an "image recording and display system." Its intended use includes image acquisition, display, and processing for use in a cardiac catheterization laboratory or radiography/fluoroscopy suite. While it aids in providing images that can be used for diagnosis, the device itself performs image capture and presentation, not interpretation or diagnosis.
No
The device description explicitly states it is a "Digital image recording and display system," implying hardware components for image acquisition and display, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is focused on image acquisition, display, processing, and patient data management within a cardiac catheterization laboratory or radiography/fluoroscopy suite. This describes a system for handling medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description confirms it's a "Digital image recording and display system." This aligns with medical imaging equipment, not IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is centered around the handling and display of medical images, which is a different category of medical device.
N/A
Intended Use / Indications for Use
- Image Acquisition .
- . Display Control/Image Processing
- Input /Output Control .
- . Patient Data Management
Product codes
Not Found
Device Description
Digital image recording and display system fo use in a cardiac catheterization laboratory or radiography/fluoroscopy suite.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiac catheterization laboratory or radiography/fluoroscopy suite.
Description of the training set, sample size, data source, and annotation protocol
Not Required
Description of the test set, sample size, data source, and annotation protocol
Not Required
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo for Camtronics Medical Systems. The logo consists of a stylized "C" shape on the left, with three horizontal lines inside. To the right of the "C" is the word "Camtronics" in a sans-serif font, with the words "MEDICAL SYSTEMS" in smaller letters below. The logo is black and white.
Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The sequence appears to be 'K954159'. The characters are written in a dark ink, and the background is white. The characters are somewhat stylized, with the '9' having a distinct loop at the top.
510(k) Summary
MAR 1 9 1996
Date prepared: August 28, 1995
Name of contact person: Robert Kriedermann
Device trade name: Digital Imaging System Common name: Digital Imaging System
Classification name: Medical Image Picture Archiving and Communications Device
Predicate substantially equivalent devices: Camtronics Ltd. Video Plus (K941979), Siemens Medical Systems Fluorospot H version 2 (K914525)
Device description: Digital image recording and display system fo use in a cardiac catheterization laboratory or radiography/fluoroscopy suite.
Intended use:
- Image Acquisition .
- . Display Control/Image Processing
- Input /Output Control .
- . Patient Data Management
Predicate device specifications comparison:
| Principal Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Feature | Camtronics Digital | ||
| Imaging System | Camtronics Video Plus | ||
| (K941979) | Siemens Fluorospot H | ||
| version 2 (K914525) | |||
| Matrix size | $512^2$ to $2068^2$ | $512^2$ to $1024^2$ | $1024^2$ |
| Max. acquisition rate | 60 fps | 60 fps | 8 fps |
| Bit depth | 8, 10, or 12 | 8 | 8 |
| Image storage | 1 gigabyte minimum | 1 gigabyte minimum | 650 megabyte |
| Networking | yes | yes | yes |
| Supported procedures | |||
| Fluoro Acquisition | yes | yes | yes |
| Fluoro Loop Record | yes | yes | yes |
| Roadmapping Fluoro | |||
| Acquisition | yes | yes | yes |
| Spot Film Verification | yes | yes | yes |
| Digital Spot Acquisition | yes | yes | yes |
| Digital Subtraction | |||
| Angiography | |||
| Acquisition (DSA) | yes | yes | yes |
| Peripheral Angiography | |||
| Acquisition (PERI) | yes | no | yes |
| Digital Tomography | |||
| Acquisition (TOMO) | yes | no | yes |
| Rotational Angiography | |||
| Acquisition | yes | no | yes |
| ECG Gated Acquisition | yes | no | no |
| ECG Trace(s) Display | yes | no | no |
| Cine | yes | yes | no |
| Filmless Cine | yes | yes | no |
| Electrophysiology (EP) | yes | no | no |
| Synchronized Biplane | |||
| Acquisition | yes | yes | no |
1
Page 2 Camtronics Digital Imaging System 510(k) Summary August 28, 1995
| Principal Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Feature | Camtronics Digital | ||
| Imaging System | Camtronics Video Plus | ||
| (K941979) | Siemens Fluorospot H | ||
| version 2 (K914525) | |||
| Window/level | yes | yes | yes |
| Edge enhancement | yes | yes | yes |
| Zoom | yes | yes | yes |
| Roam | yes | yes | yes |
| Roadmapping | yes | yes | yes |
| Peak opacification | yes | yes | yes |
| Remask | yes | yes | yes |
| Pixel shift | yes | yes | yes |
| Annotation | yes | yes | no |
| Qualitative analysis | yes | yes | no |
Predicate device specifications comparison (continued):
ನ್
ance 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