(126 days)
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No
The document describes a medical image management and processing system with standard functionalities like display, storage, and communication. There is no mention of AI, ML, deep learning, or any related terms or concepts in the provided text. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No
The device is described as a "Medical Image Management and Processing System" that displays, processes, and archives medical data to support diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states, "It supports the physician in diagnosis."
Yes
The device description explicitly states "MedDream is a software only Medical Image Management and Processing System".
Based on the provided information, MedDream is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc.
- MedDream's Function: MedDream is described as a Medical Image Management and Processing System. Its primary functions are displaying, processing, storing, and managing medical images (like X-rays, CT scans, mammograms) and related data. It works with data that is already generated, not by analyzing biological specimens.
- Intended Use: The intended use clearly states it supports the physician in diagnosis by providing access to and processing of medical images and data. It does not perform tests on biological samples.
Therefore, MedDream 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
MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive.
It supports the physician in diagnosis.
For primary image diagnosis in Mammography only uncompressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants.
Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes.
For users in the United States of America: Mobile device display is not intended for diagnostic purposes.
Product codes
LLZ
Device Description
MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive.
Mentions image processing
MedDream is a software only Medical Image Management and Processing System
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to physicians, radioal technicians, and assistants.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle. The FDA acronym and the agency's full name are in blue.
Softneta UAB % Raymond Kelly Consultant Licensale Inc 3422 Leonardo Lane NEW SMYRNA BEACH FL 32168
Re: K222320
Trade/Device Name: MedDream Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: November 8, 2022 Received: November 8, 2022
December 6, 2022
Dear Raymond Kelly:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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) K222320
Device Name
MedDream
Indications for Use (Describe)
MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive.
It supports the physician in diagnosis.
For primary image diagnosis in Mammography only uncompressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants.
Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes.
For users in the United States of America: Mobile device display is not intended for diagnostic purposes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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