(27 days)
Not Found
No
The description focuses on traditional image processing techniques (reconstruction, parallel/non-parallel beams) and data formatting/display, with no mention of AI or ML algorithms.
No.
The device is described as an image processing system for diagnostic imaging, not for treating diseases or conditions.
Yes
The device is used for the acquisition, processing, and display of scintigraphy camera output data, which are then used to show kinetic attributes of image organs. This processing and display of medical images for analysis to assess organ function falls under diagnostic purposes.
No
The device description explicitly states it is an "image processing system, which is interfaced to gamma cameras." This indicates a hardware component (the interface to the gamma camera) is part of the system, even if the core function is software-based image processing.
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 this device processes and displays data acquired directly from a gamma camera, which is used for imaging the human body in vivo (within the living organism).
- The device processes image data, not biological samples. The focus is on acquiring, formatting, storing, processing, and displaying images, not on analyzing biological fluids or tissues.
The device is an image processing system for nuclear medicine imaging, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The WBR- fHR and the WBR - fWB are 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 - thr, wBR - wb are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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
90 KPS
Device Description
The WBR -- fHR and the WBR -- fWB are image processing systems, which are interfaced to gamma cameras. Camera- fast acquired data is reconstructed by the WBR - FHR or processed by the WBR - fWB, which utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PAC'S 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
Not Found
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 that are back projection reconstructed. No adverse affects have been detected.
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
MAR 1 1 2004
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
Proprietary Device Name : WBR - fHR , WBR - fWB.
Establishment Name and Registration Number of Submitter
Name: UltraSPECT Ltd. Corresponding Official: Dan Laor Building 30, MATAM Haifa, 31905 Israel
Device Classification
Classification Code: Panel Identification: Classification Name: Common Name: Classification Class:
90 KSP Radiology Image processing (per 21CFR 892.1200 ) SPECT Imaging system Class II Product
Reason for 510(k) Submission
Special 510(k) Submission
Identification of Legally Marketed Equivalent Devices
K031874 WBR - WB
Device Description
The WBR -- fHR and the WBR -- fWB are image processing systems, which are interfaced to gamma cameras. Camera- fast acquired data is reconstructed by the WBR - FHR or processed by the WBR - fWB, which utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PAC'S device, which is DICOM or Interfile compatible.
Intended Use of Device
The WBR- fHR and the WBR - fWB are 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 that are back projection reconstructed. No adverse affects have been detected.
Substantial Equivalency
It is UltraSPECT opinion that the WBR- fHR and the WBR -- fWB are substantially equivalent in terms of safety and effectiveness to the above predicate device.
1
Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines extending from their heads. The seal appears to be a government or official emblem.
Food and Drug Administration 9200 Corporate Boulevard · Rockville MD 20850
MAR 1 1 2004
Mr. Dan Laor Quality Manager UltraSPECT, Ltd. P.O. Box 15010, MATAM Haifa, 31905 ISRAEL
Re: K040370
Trade/Device Name: WBR-fHR, WBR-fWB Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II
Product Code: 90 KPS Dated: February 8, 2004 Received: February 17, 2004
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 such 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
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Page 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):
510(k) Number (if known):
DEVICE NAME: WBR - fHR, WBR - fWB
INDICATION FOR USE: The WBR - thr, wBR - wb are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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 |
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K040370