(30 days)
Not Found
No
The summary describes image processing and reconstruction techniques, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an "image processing system" for "acquisition, formatting and storage of scintigraphy camera output data." Its function is to process and display images, not to directly treat or diagnose a disease state.
Yes
Justification: The device is indicated for the "acquisition, formatting and storage of scintigraphy camera output data" and "processing and displaying the acquired information in traditional formats,". This processing of medical imaging data is a key function of diagnostic devices. Although it does not explicitly state "diagnosis," its function of processing data to show "kinetic attributes of the image organs" and producing "high resolution images" from gamma camera data is inherently for aiding in the clinical evaluation and interpretation of images, which are core to diagnostic processes.
No
The device description explicitly states it is "interfaced to gamma cameras" and processes "gamma camera cardiac, fast acquired, data," indicating a dependency on and interaction with hardware (gamma cameras) beyond just software functionality.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Xpress3.Cardiac is described as an image processing system that acquires, formats, stores, processes, and displays data from a scintigraphy camera. Scintigraphy is an imaging technique that uses radioactive tracers injected into the body to create images of organs and tissues.
- Lack of Sample Analysis: The device does not analyze biological samples taken from the body. It processes data generated by an imaging modality (scintigraphy) that visualizes processes within the body.
Therefore, the Xpress3.Cardiac falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Xpress3.cardiac 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, LLZ
Device Description
The Xpress3.cardiac is an image processing system, which is interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the Xpress3.cardiac. The Xpress3.cardiac utilizes parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
Mentions image processing
The Xpress3.cardiac is an image processing system
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scintigraphy camera
Anatomical Site
cardiac, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by Filtered Back - Projection.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K08120/
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(
Device Name
Proprietary Device Name: Xpress3.cardiac.
Establishment Name and Registration Number of Submitter
MAY 2 8 2008
Name: UltraSPECT Ltd. Corresponding Official: Dan Laor Sireni 6. Haifa 32972, Israel TEL: 972-4-8246632
Device Classification
| Product Code: | KPS |
|---|---|
| Subsequent Product Code | LLZ |
| CFR section: | 892.1200 |
| Panel Identification: | Radiology |
| Device Description: | Emission computed tomography system |
| Classification: | Class II Product |
Reason for 510(k) Submission
Special 510(k) Submission
Identification of Legally Marketed Predicate Devices
WBR Xact.cardiac & Xpress.cardiac - K050815 including Half Dose K080784
Device Description
The Xpress3.cardiac is an image processing system, which is interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the Xpress3.cardiac. The Xpress3.cardiac utilizes parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
Intended Use of Device
The Xpress3.cardiac 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
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 images that are reconstructed by Filtered Back - Projection.
Substantial Equivalency
It is UltraSPECT opinion that the Xact.cardiac & Xpress.cardiac are substantially equivalent in terms of safety and effectiveness to the above predicate device.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2008
UltraSPECT, Ltd. % Mr. Dan Laor Managing Director Quasar Quality, Ltd. 6 Sireni. Haifa. 32972 ISRAEL
Re: K081201
Trade/Device Name: Xpress3.Cardiac Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and LLZ Dated: April 22, 2008 Received: April 28, 2008
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.
2
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
Nancy C.Bridgton
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Xpress3.Cardiac
Indications For Use:
The Xpress3.Cardiac 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, ind in various forms of animated sequences, showing kinetic attributes of the image organs.
K08/201
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Arzu In Khang
(Division Sign-Off)
(Division Sign-C Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _