(30 days)
KPS, LLZ
No
The summary describes image processing and reconstruction techniques, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic development.
No
The device is an image processing system for scintigraphy camera output data, used for processing and displaying medical images, not for administering therapy.
No
The device is described as an "image processing system" that "reconstructs" and "displays" acquired information from scintigraphy cameras. While it produces high-resolution images that can be transferred to other PACS devices, its primary function is processing and presenting data, not interpreting or diagnosing medical conditions from that data. The information provided focuses on image acquisition, formatting, storage, and reconstruction, with no mention of automated analysis for diagnostic purposes.
No
The device description explicitly states that the systems are "interfaced to gamma cameras" and process "gamma camera cardiac, fast acquired, data". This indicates a dependency on and interaction with hardware (gamma cameras) beyond just software processing.
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 this device is an "image processing system" that interfaces with "gamma cameras" to process and display "scintigraphy camera output data." This involves processing images generated outside the body, not analyzing samples taken from the body.
- Intended Use: The intended use is focused on the "acquisition, formatting and storage of scintigraphy camera output data" and "processing and displaying the acquired information." This is related to medical imaging, not in vitro testing.
Therefore, the WBR Xpress3.Cardiac and WBR Xpress.Cardiac are medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections 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 imaged organs
Product codes
KPS, LLZ
Device Description
The Xpress.cardiac & Xpress3.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the devices, which utilize 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. The devices have been modified by including Attenuation and Scattering Corrections (ACSC).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scintigraphy camera
Anatomical Site
Organs (imaged 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 and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate Xeleris 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
MAY 14 2009
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(t))
Device Name
Proprietary Device Name: Xpress.cardiac & Xpress3.cardiac including Attenuation & Scattering Corrections
Establishment Name and Registration Number of Submitter
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
Xpress.cardiac - K080784, Xpress3.cardiac - K081201 Xeleris - K051673
Device Description
The Xpress.cardiac & Xpress3.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the devices, which utilize 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. The devices have been modified by including Attenuation and Scattering Corrections (ACSC).
Intended Use of Device
The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections 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 imaged organs
Safety & Effectiveness
The device has been designed, verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate Xeleris device.
Substantial Equivalency
It is UltraSPECT opinion that the modified Xpress.cardiac & Xpress3.cardiac are substantially equivalent in terms of safety and effectiveness to the predicate devices.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 1 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UltraSPECT Ltd. % Mr. Dan Laor Quality & Regulatory Advisor Quasar Quality Ltd 6 Sireni. Haifa 32972 İSRAEL
Re: K091073
Trade/Device Name: Xpress.Cardiac & Xpress3.cardiac including Attenuation & Scattering Corrections
Regulation Number: 21 CFR 892.1200
Regulation Name: Emission computed tomography system
Regulatory Class: II
Product Code: KPS and LLZ
Dated: April 12, 2009
Received: April 14, 2009
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); 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
Page 2
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.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely wours,
Janine M. Morris Acting 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):
K 09/1073
Device Name: Xpress.cardiac & Xpress3.cardiac including Attenuation & Scattering Corrections
Indications For Use:
The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections 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 imaged organs
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)
Hubert Heme
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
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