(78 days)
Not Found
No
The summary describes standard medical image processing, archiving, and viewing software without mentioning AI or ML capabilities.
No
The device is described as software for processing and managing medical images, not for providing therapy.
No
The device is described as software for processing and communicating medical images, not for diagnosing medical conditions. Its function is to facilitate the review and management of images for medical professionals, who then perform the actual diagnosis.
No
While the device is described as "software device," the device description explicitly lists hardware components (DICOMed DIG.IT image acquisition and CD recording station) as part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The AETmed Medical image processing Software is described as a software device for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images. These images are generated from imaging modalities like cardiac catheterization, echocardiography, and general radiology.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. Its function is centered around the management and processing of visual medical data.
Therefore, the device's intended use and description clearly place it outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and mard ware planeral, tor cardiac cathererization, echocardiography, and general radiological studies.
The Version 3.0 DICOMed Family Software System consists of the following components:
- DICOMed DIG.IT image acquisition and CD recording station o
- DICOMed P@CS image archiving manager o
- DICOMed Review Cardio review workstation for cardiology o
- DICOMed Review diagnostic review workstation for radiology o
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
qualified medical professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
AETmed, S.p.A. Viale Cembrano, 4C 16148 Genova, Italy Phone: 39010307091 390103070937 Facsimile: Contact Person: Massimiliano Peri April 30, 2001 Date: 807.92(a)(2) Trade Name: AETmed Image Processing Software Common Name: Image Processing Software Classification Name(s): System, Image Processing Classification Number: LLZ 807.92(a)(3) Predicate Device(s) Electromed View NT K000474 Applicare Radworks Medical Imaging K982862 Software with Quality Control Module Cemax-Icon Accurad Image management System; K955092
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
AutoRad Regustr
1
807.92(a)(4)
Device Description
The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and mard ware planeral, tor cardiac cathererization, echocardiography, and general radiological studies.
The Version 3.0 DICOMed Family Software System consists of the following components:
- DICOMed DIG.IT image acquisition and CD recording station o
- DICOMed P@CS image archiving manager o
- DICOMed Review Cardio review workstation for cardiology o
- DICOMed Review diagnostic review workstation for radiology o
2
807.92(a)(5)
Intended Use(s)
The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.
3
| Feature | Product | AETmed Image
Processing software
(This submission) | VIEW NTTM | Radworks Medical
Imaging Software
with Quality Control
Module | Accurad Image
Management System,
AutoRad Regustr |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Manufacturer | AETmed | Electromed | Applicare | Cemax Icon | |
| 510(k) Number | K000474 | K982862 | K955092 | | |
| Classification | 892.2050; Class II | 892.2050; Class II | 892.2050; Class II | 892.2050; Class II | |
| Intended Use | The AETmed Medical
image processing
Software is a software
device intended to be
used by qualified
medical professionals,
after proper installation
on an appropriate
hardware platform, for
capturing, retrieving,
viewing, processing,
printing, archiving, and
communicating
medical images, such
as cardiac
catheterisation, echo-
cardiography, and
general radiological
studies. | VIEW NT is a
powerful real-time
cardiac image
acquisition, display,
processing and
communication system
enhancing the
performance of a
Cathlab and its
connection to the
Digital Image
Archiving network.
Both Quantitative
Coronary Analysis and
Ventricular Analysis
Software's are included
with the VIEW NT. | The RadWorks
Medical Imaging
Software, from
Applicare Medical
Imaging, B.V., when
installed on an
appropriate hardware
platform, is intended to
provide capability for
the acceptance, display,
storage, and digital
processing of medical
images. Options allow
for additional
capability, including
transmission of images
over local area
networks or public
communications
channels, digitization
of film images,
acceptance of digital
images directly from
different medical image
modalities, and quality
control review and
revision of studies. | Cemax Icon provides
PACS, computed
radiography and
teleradiology software.
The software is
scalable and addresses
all aspects of medical
image acquisition,
viewing, storage and
printing. | |
| Graphical User
Interface | Yes | Yes | Yes | Yes | |
| Platform | PC | PC | PC | Workstation | |
| Operating System | Windows NT,
Windows 2000 | Windows NT | Windows NT | UNIX | |
| Display Resolution | Up to 2048x2560 | 1024x768 | Up to 2048x2560 | Up to 2048x2560 | |
| | | | | | |
| Feature | | | | | |
| Product | AETmed Image
Processing software
(This submission) | VIEW NTTM | Radworks Medical
Imaging Software
with Quality Control
Module | Accurad Image
Management System,
AutoRad Regustr | |
| Gray scale resolution | From 8 bits, 256 levels
to 24 bits true color | 8 bits, 256 levels | From 8 bits, 256 levels
to 24 bits true color | From 8 bits, 256 levels
to 24 bits true color | |
| Multi-monitor
support | Yes | Yes | Yes | Yes | |
| Patient Demographics | Yes | Yes | Yes | Yes | |
| Networking | TCP/IP | TCP/IP | TCP/IP | TCP/IP | |
| Image
Communication | DICOM Compliant | DICOM Compliant | DICOM Compliant | DICOM Compliant | |
| DICOM Compliant | Yes | Yes | Yes | Yes | |
| Image Compression | JPEG loss-less | JPEG loss-less, JPEG
lossy | JPEG loss-less, JPEG
lossy | JPEG loss-less, JPEG
lossy | |
| Video signals
grabbing | Yes | Yes | Yes | Unknown | |
| Analogic Video Input
format | 525, 625, 1023, 1049,
1249; interlaced or
progressive | 525, 625, 1023, 1049,
1249; interlaced or
progressive | 525, 625; interlaced or
progressive | N/A | |
| Analogic Video Input
rate |