(51 days)
Not Found
No
The document describes standard medical image management software functionalities (acquiring, viewing, processing, archiving, reporting, communicating) and explicitly states it does not influence image production or control emissions. There is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No.
The software is for managing and viewing ultrasound images, not for treating conditions.
No
The software is described as an "image management software device" that handles the acquisition, viewing, processing, archiving, reporting, and communication of ultrasound studies. While it connects to "diagnostic modalities" and helps centralize image archiving for later viewing, processing, and reporting, its primary function is management and not the direct generation of a diagnosis itself. It explicitly states, "It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes." This indicates it's a tool for managing diagnostic information, rather than a diagnostic device in its own right.
Yes
The device is described as "software" and its functions (acquiring, viewing, processing, archiving, reporting, communicating) are software-based image management tasks. While it requires an "appropriate hardware platform" for installation, the device itself is the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Ebit Sanità Org@nizer software is described as a medical image management software device. Its functions are related to acquiring, viewing, processing, archiving, reporting, and communicating ultrasound medical studies. This involves managing images generated by an external imaging modality (ultrasound), not analyzing biological samples.
- Intended Use: The intended use clearly states it's for managing digital ultrasound studies. It explicitly mentions it "does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes." This further reinforces that it's not involved in analyzing biological processes or samples.
Therefore, the Ebit Sanità Org@nizer software falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Ebit Sanità Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform.
This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving reporting and communicating digital ultrasound studies. It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes. The medical device is able to manage stand-alone or distributed medical image archives. It specifically provides the following added-value:
®Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting;
@Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.
Product codes (comma separated list FDA assigned to the subject device)
90-LLZ
Device Description
The Ebit Sanità Org@nizer software is a medical Image Management software device used for digital acquisition, viewing, processing, archiving, reporting and communicating ultrasound studies.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound studies, ultrasound medical studies
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) Ebit Sanità Org@nizer Software Ebit Sanità, S.p.A.
MAR 2 7 2003
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
Colleen Hittle Densmore, Official Correspondent
The Anson Group, an Aventor company
7992 Castleway Drive
Indianapolis, IN 46250
| Phone: | (317) 849-1916 |
|---|---|
| Facsimile: | (317) 577-9070 |
Contact Person: Colleen Hittle Densmore
| Date: | January 15, 2003 |
|---|---|
| ------- | ------------------ |
807.92(a)(2)
| Trade Name: | Ebit Sanità Org@nizer Software |
|---|---|
| Common Name: | System, Image Processing |
| Classification: | |
|---|---|
| Regulatory Class: | II |
| FR Number | Product Code | |
|---|---|---|
| Image Processing System | 892.2050 | 90-LLZ |
807.92(a)(3)
Predicate Device(s)
| Applicare | Radworks Medical Imaging Software |
|---|---|
| W/ Quality Control Module | |
| K982862 |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
1
510(k) Ebit Sanità Org@nizer Software Ebit Sanità, S.p.A.
807.92(a)(4)
Device Description
The Ebit Sanità Org@nizer software is a medical Image Management software device used for digital acquisition, viewing, processing, archiving, reporting and communicating ultrasound studies.
807.92(a)(5)
Intended Use(s)
The Ebit Sanita Org@nizer software is intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform.
2
| Product | Ebit Sanità Org@nizer
Software
(This submission) | Applicare Medical Imaging
Radworks Medical Imaging
Software with Quality Control
Module
K982862 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 892.2050 LLZ
Class II | 892.2050 LLZ
Class II |
| Intended use | The Ebit Sanità Org@nizer software
is a medical image management
software device intended to be used
for digital acquiring, viewing,
processing, archiving, reporting and
communicating ultrasound medical
studies by qualified medical
professionals, after proper
installation on an appropriate
hardware platform | The RadWorks Quality Control Module is
intended to be used by authorized staff to
perform various quality control operations on
RadWorks imaging studies before they are made
available to other locations on the network.
These operations include confirming or editing
patient characteristics, reviewing the status
history of the study, adding or removing images,
combining with another study, renumbering
images, editing patient orientation information,
and setting or editing routing information. |
| Graphic User Interface | Yes | Yes |
| Platform | PC | PC |
| Operating System | Microsoft Windows
based | Microsoft Windows
based |
| Display Resolution | 1280x1024 | 2048x2560 |
| Image Resolution | From 8 bits grayscale and 24 bits
color | From 8 bits, 256 levels to 24 bits color |
| Image Communication | DICOM Compliant | DICOM Compliant |
| Image Compression | No image compression techniques
are utilized | Jpeg Loss-less;
Jpeg lossy |
| Image Archiving (Hard
Disk) | Yes | Yes |
| Image Archiving
(Removable Media) | CD-R; DVD-R, other Dicom Entities | CD-R; MOD; DVD-R, other Dicom Entities |
| Image Review | Still frame, Cine-loops, Window-
level, Zoom, Panning, Configurable
layout | Still frame, Cine-loops, Window-Level, Zoom,
Panning, Configurable layout |
| Image Processing | Annotation:
text, lines | Annotation:
arrows, text, lines, Circles |
| | Measurements: Distance, area,
perimeter, velocity | Measurements: distances, angles, pixel values,
pixel distribution, grey level statistics |
| Image Database | Yes | Yes |
| Image Management | Uncompressed / JPEG Lossy /
JPEG Loss-less | Uncompressed / JPEG Lossy /
JPEG Loss-less |
Comparison Chart for Substantial Equivalence
.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2003
Ebit Sanita, S.p.A. % Ms. Colleen Densmore The Anson Group 7229 Castleway Drive INDIANAPOLIS IN 46250
Re: K030363
Trade/Device Name: Org(@nizer Version 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: January 31, 2003 Received: February 4, 2003
Dear Ms. Densmore:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
5
Indications for Use Statement
| Applicant: | Ebit Sanità S.p.A. |
|---|---|
| 510(k) Number (if known): | K030363 |
Ebit Sanità Org@nizer Software Device Name:
Indication For Use:
The Ebit Sanità Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform.
This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving reporting and communicating digital ultrasound studies. It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes. The medical device is able to manage stand-alone or distributed medical image archives. It specifically provides the following added-value:
®Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting;
@Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use / OR Over The Counter _
(PER 21 CFR, 801 109)
(optional Format 1-2-96)
David A. Symm
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030363
510(K) FILE - ORG@NIZER SOFTWARE