Who is the manufacturer of Medisystem Pacs?

Medilab Manutencao E Sitemas Ltda filed the 510(k) submission for Medisystem Pacs (K223048).

What is the FDA product code for Medisystem Pacs?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Medisystem Pacs?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Medisystem Pacs?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medisystem Pacs

K223048 · Medilab Manutencao E Sitemas Ltda · LLZ · Jun 23, 2023 · Radiology

Device Facts

Record ID	K223048
Device Name	Medisystem Pacs
Applicant	Medilab Manutencao E Sitemas Ltda
Product Code	LLZ · Radiology
Decision Date	Jun 23, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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.

Device Story

Web-based DICOM medical image viewer; server-based solution connecting to existing PACS or EHR/portals. Inputs: multi-modality DICOM image data (US, CT, MRI, X-Ray). Operation: accessed via web browsers (Edge, Firefox, Chrome) without client-side installation. Functions: image downloading, reviewing, manipulating, visualizing, and printing. Tools include window leveling, rotation, pan, zoom, PET fusion, volumetric rendering, and measurements (line, angle, area). Output: displayed diagnostic quality images and generated reports. Used by radiologists and healthcare professionals for study review and clinical decision-making. Benefits: enables real-time collaboration and remote access to patient imaging data.

Clinical Evidence

Bench testing only. Software verification and validation performed per FDA guidance. Performance testing conducted to verify measurement accuracy for distance (1%), angle (2%), and area (2%). No clinical data provided.

Technological Characteristics

Web-based DICOM viewer; server-based architecture. Supports DICOM standard. Compatible with Windows, Linux, and Mac OS via web browsers (Edge, Firefox, Chrome). Features include windowing, PET fusion, volumetric rendering, and measurement tools. Software level of concern: moderate.

Indications for Use

Indicated for use by qualified medical personnel in hospitals, imaging centers, and reading practices as a diagnostic and analysis tool for DICOM images (US, CT, MRI, X-Ray). Not for diagnostic use with mammography images (referral only) or on mobile devices.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

MediLab (K221065)

Related Devices

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K233226 — FlexView Diagnostic (v1.1.20) · Radical Imaging, LLC · Jan 17, 2024
K242362 — Lightning Viewer · Nexsys Electronics Inc. Dba Medweb · Dec 20, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 | {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 | {6}------------------------------------------------ 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 {7}------------------------------------------------ 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.