(267 days)
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No
The document describes a standard PACS system for viewing and managing medical images. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is described as a diagnostic and analysis tool for medical images, not for treating any conditions or diseases.
Yes
The "Intended Use / Indications for Use" section states: "MediSystem PACS is intended for use as a diagnostic and analysis tool for diagnostic images". This explicitly labels it as a diagnostic device.
Yes
The device description explicitly states it is a "Web-based DICOM medical image viewer" and a "server-based solution" that displays images within a web browser without requiring client software installation. This indicates the device's primary function and delivery method are software-based. While it interacts with hardware (client machines, servers, PACS), the core medical device functionality described is the software itself.
Based on the provided information, the MediSystem PACS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of MediSystem PACS clearly states it is a medical image viewer that displays and manages diagnostic quality DICOM images from various imaging modalities (US, CT, MRI, XRay). It works with images of the patient's anatomy, not with biological samples or specimens.
- The intended use is for diagnostic and analysis of diagnostic images. This aligns with the function of a medical image viewer, not a device that performs tests on biological samples.
Therefore, MediSystem PACS falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MediSystem PACS is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediSystem PACS displays and manages diagnostic quality DICOM images. MediSystem PACS is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediSystem PACS is not intended for diagnostic use on mobile devices.
Contraindications: MediSystem PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
Product codes
LLZ
Device Description
The MediSystem PACS is a Web-based DICOM medical image viewer that allows downloading, reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediSystem PACS is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. MediSystem PACS enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software. Supported Web browsers are: Microsoft Edge 79 or later, Mozilla Firefox 58 or later, Google Chrome 63 or later.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
US, CT, MRI, XRay
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance Testing (Measurement Accuracy) was conducted on the MediSystem PACS to determine measurement accuracy when performing the various distance, area and angle measurements.
Key Metrics
Measurement accuracy: 1% for distance, 2% for angle and distance.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Medilab Manutencao E Sitemas Ltda Jorge Millan Regulatory Consultant Rua Amaral, 80, Andarai Rio De Janeiro, Rio De Janeiro 20541-155 Brazil
June 23, 2023
Re: K223048
Trade/Device Name: Medisystem Pacs Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: May 22, 2023 Received: May 23, 2023
Dear Jorge Millan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223048
Device Name MediSystem PACS
Indications for Use (Describe)
MediSystem PACS is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediSystem PACS displays and manages diagnostic quality DICOM images. MediSystem PACS is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediSystem PACS is not intended for diagnostic use on mobile devices.
Contraindications: MediSystem PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Medilab. The logo consists of a blue square with a white "M" inside, followed by the word "medilab" in black. Below the word "medilab" is the word "SISTEMAS" in a smaller font, and below that is the text "MEDILAB MANUTENCAO E SISTEMAS LTDA" in a larger font.
MediSystem PACS 510K Summary – June 21, 2023
510(K) Summary
Submitter Information
| Submitter | MEDILAB MANUTENCAO E SISTEMAS LTDA
RUA AMARAL, 80, ANDARAI
Rio de Janeiro, Brazil 20541-155 |
|------------------|---------------------------------------------------------------------------------------------------|
| Contact: | Jorge Millan, PhD |
| Telephone number | (786) 416-5587 |
| E-mail | jmillan@sigmabiomedical.com |
| Date prepared: | June 21, 2023 |
Subject Device Name
| Trade/Proprietary Name: | MediSystem PACS |
|---|---|
| Regulation Number: | 892.2050 |
| Regulation Name: | Medical Image management and processing system |
| Product Code: | LLZ |
| Class | II |
| Panel | Radiology |
Predicate Device
| Predicate Device: | MediLab |
|---|---|
| Sponsor | SIGMA SCIENTIFIC SERVICES LLC |
| 510(K) | K221065 |
| Regulation Number: | 892.2050 |
| Regulation Name: | Medical Image management and processing system |
| Product Code: | LLZ |
| Class | II |
| Panel | Radiology |
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Image /page/4/Picture/0 description: The image shows the logo for Medilab, which includes the company name and the word "Sistemas" in smaller letters below. The text "MEDILAB MANUTENCAO E SISTEMAS LTDA" is present below the logo. The image also contains the text "MediSystem PACS 510K Summary - June 21, 2023".
Device Description:
The MediSystem PACS is a Web-based DICOM medical image viewer that allows downloading. reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediSystem PACS is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. MediSystem PACS enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software. Supported Web browsers are: Microsoft Edge 79 or later, Mozilla Firefox 58 or later, Google Chrome 63 or later.
Indications for Use:
MediSystem PACS is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediSystem PACS displays and manages diagnostic quality DICOM images. MediSystem PACS is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediSystem PACS is not intended for diagnostic use on mobile devices.
Contraindications: MediSystem PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
Non-Clinical Data:
Non-clinical product evaluation to demonstrate safety and effectiveness was conducted. Non-clinical testing includes:
Software Verification and Validation
Software verification and validation testing were conducted on the MediSystem PACS and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent
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Image /page/5/Picture/0 description: The image shows the logo for Medilab Sistemas, followed by the text "MEDILAB MANUTENCAO E SISTEMAS LTDA". Below this is the text "MediSystem PACS 510K Summary - June 21, 2023". The logo consists of the word "medilab" in a bold, sans-serif font, with a blue square containing the letter "m" to the left of the word. Below the word "medilab" is the word "SISTEMAS" in a smaller font.
flaw in the software would lead to a delayed delivery of appropriate medical care. Documentation includes level of concern, software requirements and specifications, design architecture, risk analysis and software validation and verification.
Performance Testing (Measurement Accuracy) was conducted on the MediSystem PACS to determine measurement accuracy when performing the various distance, area and angle measurements.
Predicate Devices
MediSystem PACS is equivalent to MediLab by SIGMA SCIENTIFIC SERVICES LLC cleared under K221065.
Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]: MediSystem PACS is comparable
with and substantially equivalent to MediLab System.
Technical Characteristics Comparison:
The basic and main technical features of the subject device are the same as the predicated device
Feature Comparison:
Subject device has similar features and functionality as the predicate device:
Product comparison
| Feature | MEDILAB | MEDISYSTEM PACS |
|---|---|---|
| K# | K221065 | |
| Intended Use | MediLab software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediLab displays and manages diagnostic quality DICOM images. Medilab is not intended for diagnostic use with mammography images. Usage for mammography is | MediSystem PACS software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediSystem PACS displays and manages diagnostic quality DICOM images. MediSystem PACS is not intended for diagnostic use with |
| for reference and referral only. | ||
| MediLab is not intended for | ||
| diagnostic use on mobile devices. |
Contraindications: MediLab is not
intended for the acquisition of
mammographic image data and is
meant to be used by qualified
medical personnel. | mammography images. Usage for
mammography is for reference and
referral only. MediSystem PACS is
not intended for diagnostic use on
mobile devices.
Contraindications: MediSystem
PACS is not intended for the
acquisition of mammographic
image data and is meant to be used
by qualified medical personnel. |
| Mammographic use | No | No |
| DICOM image loading and
visualization | Yes | Yes |
| Patient study search data | Yes | Yes |
| User authentication | Yes | Yes |
| Window level | Yes | Yes |
| Rotate/pan/zoom/fit to screen | Yes | Yes |
| Image display operations | Flip horizontal, vertical
Rotate left, right
Clear transform
Magnification
Scroll
Layout 1x1 -3x3
Thumbnails left, right, top,
bottom
PET Fusion
Volumetric rendering | Flip horizontal, vertical
Rotate left, right
Clear transform
Magnification
Scroll
Layout 1x1 -3x3
Thumbnails left, right, top,
bottom
PET Fusion
Volumetric rendering |
| Measurement functions | Line, angle, area | Line, angle, area |
| Measurement accuracy | 1% for distance
2% for angle and distance | 1% for distance
2% for angle and distance |
| Annotations | Text | Text |
| Report Generation | Yes | Yes |
| Print reports | PDF | PDF |
| Export | Yes | Yes |
| Export reports to CD | No | No |
| Share function | Yes | Yes |
| DICOM Windowing | Yes | Yes |
| Low Pass Filter | No | No |
| Imaging modalities | US, CT, MRI, XRay | US, CT, MRI, XRay |
| Communications | DICOM | DICOM |
| Operating System for Diagnostic
Viewing | Windows, Linux, Mac | Windows, Linux, Mac |
| Browser supported | Edge, Firefox, Chrome | Edge, Firefox, Chrome |
| Mobile Device Support for Viewing | No | No |
| Transfer/Storage/Display of Medical
images | Yes | Yes |
| | Network access | Connects to existing PACS |
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Image /page/6/Picture/0 description: The image shows the logo for Medilab Sistemas. The logo features a blue square with a white "m" inside, followed by the word "medilab" in black, sans-serif font. Below the word "medilab" is the word "SISTEMAS" in a smaller, sans-serif font.
MEDILAB MANUTENCAO E SISTEMAS LTDA
MediSystem PACS 510K Summary – June 21, 2023
SECTION 9
Page 4 of 5
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Image /page/7/Picture/0 description: The image shows the logo for Medilab Sistemas. The logo features a blue square with a white "m" inside it, followed by the word "medilab" in black, sans-serif font. Below the word "medilab" is the word "SISTEMAS" in a smaller, sans-serif font.
LAB MANUTENCAO E SISTEMAS LTDA
MediSystem PACS 510K Summary - June 21, 2023
Evaluation of similarities and differences:
- MediSystem PACS and MediLab have similar intended use, functionality and similar Web . technologies. In terms of use and functions both systems access, upload and display DICOM images and metadata and provide tools and resources to the physician for study review and analysis. Both systems are hosted in Web servers and are equipped with security features and user authentication.
- There are no differences between both systems. ●
Conclusion:
The subject device has similar technology characteristics and has similar intended use and functionality as the predicate device. Product testing included software validation and performance testing such as distance, area and angle measurement accuracy. These tests show similar and equivalent performance. Thus, there are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness. The non-clinical performance test data and software verification and validation demonstrate that the MediSystem PACS performs comparably to and it is as safe and effective as the predicate device. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, MediSystem PACS is substantially equivalent to the predicate that is currently marketed for the same intended use.