(21 days)
No
The summary describes image processing and reconstruction techniques, but there is no mention of AI, ML, or related terms.
No
The device is described as an image processing system for scintigraphy camera output data, designed for acquisition, formatting, storage, processing, and display of images. Its function is to reconstruct and display high-resolution images, not to treat or alleviate a disease or condition.
No
Explanation: The device is an image processing system that processes and displays scintigraphy camera output data. It does not perform a diagnostic function itself, but rather aids in the visualization of diagnostic images.
No
The device is described as an "image processing system, which is interfaced to gamma cameras." This implies a hardware component for interfacing with the gamma camera and potentially for processing the data, in addition to the software. The description does not explicitly state it is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the WBR-HR processes and stores data acquired directly from a gamma camera, which is an imaging device used on a patient, not a device that analyzes biological specimens.
- The focus is on image processing and display. The device's function is to take image data from a gamma camera and process, format, and display it. This is characteristic of medical imaging software or systems, not IVDs.
- There is no mention of analyzing biological samples. The description does not involve blood, urine, tissue, or any other type of biological specimen.
Therefore, the WBR-HR falls under the category of medical imaging software or a medical image processing system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The WBR- HR is indicated for acquiring gamma camera output data. It is capable of processing the acquired information, store it and display the resulted images in traditional formats.
The WBR- HR is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
Product codes
KPS
Device Description
The WBR - HR is an image processing system, which is interfaced to gamma cameras. The camera-acquired data is reconstructed by the WBR - HR, which utilizes parallel and non - parallel beams and produces high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma camera, scintigraphy camera
Anatomical Site
Image organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to the images of the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
APR 0 9 2003
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(n))
Device Name
Proprietary Device Name : WBR -HR
Establishment Name and Registration Number of Submitter
Name: U.C.G. Technologies Ltd. Corresponding Official: Dan Laor Building 30, MATAM
Haifa, 31905 Israel
Device Classification
Classification Code: Panel Identification: Classification Name: Common Name: Classification Class:
KPS 90 FEZ Radiology 1200 Image processing (per 21CFR 892.2050 ) SPECT Imaging system Class II Product
Reason for 510(k) Submission
Fraditional 510(k) Submission
ission Special
Identification of Legally Marketed Equivalent Devices
K972886 Mirage system
Device Description
The WBR - HR is an image processing system, which is interfaced to gamma cameras. The camera-acquired data is reconstructed by the WBR - HR, which utilizes parallel and non - parallel beams and produces high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
Intended Use of Device
The WBR- HR is indicated for acquiring gamma camera output data. It is capable of processing the acquired information, store it and display the resulted images in traditional formats.
Safety & Effectiveness
The device has been designed verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to the images of the predicate device. No adverse affects have been detected.
Substential Equivalency
It is U.C.G opinion that the WBR-HR is substantially equivalent in terms of safety and effectiveness to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement. The overall design is simple and conveys a sense of health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan Laor Ouality Manager U.C.G. Technologies, Ltd. P.O. Box 15010. MATAM Haifa, 31905 ISRAEL
Re: K030870
APR 0 9 2003
Trade/Device Name: WBR-HR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: March 13, 2003 Received: March 19, 2003
Dear Mr. Laor:
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.
2
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 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
3
510(k) Number (if known):
DEVICE NAME: WBR HR
INDICATION FOR USE: The WBR- HR is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
(Please do not write below this line - continue on another page if needed)
( Concurrence of CDRH, Office of Device Evaluation (ODE) )
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR Over-the-Counter Use
| (Division Sign-Off) | Nancy C. Brogdon |
|---|---|
| Division of Reproductive, Abdominal, Radiological Devices | |
| 510(k) Number | K030800 |