(90 days)
Not Found
None
No
The summary describes a system for image storage, communication, processing, and display, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as receiving, storing, communicating, processing, and displaying digital images and data for trained professionals. Its function does not involve treating or curing a disease or condition.
No
Explanation: The provided text describes a system for receiving, storing, communicating, processing, and displaying medical images and data. While it handles medical imaging data, it does not explicitly state that it analyzes this data to provide a diagnosis or aid in diagnosis. Its function is primarily data management and visualization rather than interpretation for diagnostic purposes.
Unknown
The provided text describes a system that receives, stores, communicates, processes, and displays digital images and data. While these are software functions, the description does not explicitly state that the device is only software. It mentions receiving data from various hardware sources (scanners, units, etc.) and operating within a "system," which could potentially include dedicated hardware components not explicitly detailed in this summary. Without a "Device Description" section or a clear statement of being software-only, it's impossible to definitively confirm its software-only nature from this text alone.
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 description clearly states that the UniSight™ system receives, stores, communicates, processes, and displays digital images and data from various medical imaging modalities (CT, MR, ultrasound, etc.).
- Lack of biological sample analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the body. Its function is centered around handling and processing medical images.
Therefore, the UniSight™ system with UniGate™ falls under the category of medical imaging software or picture archiving and communication systems (PACS), not in vitro diagnostics.
N/A
Intended Use / Indications for Use
UniSight™ system with UniGate™ is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer network at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.
Product codes
90 LLZ
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to physicians, nurses and technicians.
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)
Not Found
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 7 2003
Electronic Business Machine Co., Ltd. % Mr. David Lin North America EBM Technologies, Inc. 1600 Kapiolani Boulevard, Suite 1224 HONOLULU HI 96814
Re: K023394
Trade/Device Name: EBM UniSight™ System with UniGate™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 2, 2002 Received: October 9, 2002
Dear Mr. Lin:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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 yours,
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
2
Indications for Use Statement
| 510(k) Number
| (if known) | K023394 |
|---|---|
| Device Name | EBM UniSight™ System with UniGate™ |
| Indications for Use | UniSight™ system with UniGate™ is a device that receives |
| digital images and data from various sources (including but not | |
| limited to CT scanners, MR scanners, ultrasound systems, R/F | |
| Units, computed & direct radiographic devices, secondary capture | |
| devices, scanners, imaging gateways or other imaging sources). | |
| Images and data can be stored, communicated, processed and | |
| displayed within the system and or across computer network at | |
| distributed locations. Typical users of this system are trained | |
| professionals, including but not limited to physicians, nurses and | |
| technicians. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __
OR
(Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023394
Page _________________________________________________________________________________________________________________________________________________________________________ of __
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