XACT.CARDIAC & XPRESS.CARDIAC

K050815 · Ultraspect , Ltd. · KPS · Apr 26, 2005 · Radiology

Device Facts

• Record ID: K050815
• Device Name: XACT.CARDIAC & XPRESS.CARDIAC
• Applicant: Ultraspect , Ltd.
• Product Code: KPS · Radiology
• Decision Date: Apr 26, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The WBR Xact.cardiac & Xpress.cardiac is 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.

Device Story

Xact.cardiac and Xpress.cardiac are image processing systems interfacing with gamma cameras. Systems ingest raw scintigraphy camera data; perform image reconstruction using parallel and non-parallel beam processing; generate high-resolution 2D images, pseudo 3D renderings, and animated sequences of organ kinetics. Used in clinical settings by radiology staff. Output transferred via DICOM or Interfile to PACS for physician review. Enhances image resolution compared to traditional filtered back-projection, aiding clinical diagnostic decision-making.

Clinical Evidence

Bench and clinical data provided. Comparison against traditional filtered back-projection reconstruction methods demonstrated that the device produces images of equivalent or better resolution. No adverse effects reported.

Technological Characteristics

Image processing system for gamma camera data; utilizes parallel and non-parallel beam reconstruction algorithms; DICOM and Interfile compatible; software-based image processing; designed per 21 CFR 820.30.

Indications for Use

Indicated for the acquisition, formatting, and storage of scintigraphy camera output data for clinical imaging, including pseudo 3D renderings and animated sequences of organ kinetics.

Regulatory Classification

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.

Predicate Devices

• Mirage Workstation (K972886)
• WBR - fHR and WBR -fWB (K040370)

Submission Summary (Full Text)

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K050815

## 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))

#### Device Name

Proprietary Device Name: Xact.cardiac & Xpress.cardiac.

## Establishment Name and Registration Number of Submitter

Name: UltraSPECT Ltd. Corresponding Official: Dan Laor

Building 30, MATAM Haifa, 31905 Israel

#### Device Classification

Device Code: CFR section: Panel Identification: Device Description: Classification:

90 KPS 892.1200 Radiology Emission computed tomography system Class II Product

### Reason for 510(k) Submission

Special 510(k) Submission

## Identification of Legally Marketed Equivalent Devices

Mirage Workstation (K972886) WBR - fHR and WBR -fWB (K 040370)

#### Device Description

The Xact.cardiac & Xpress.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac data is reconstructed by the Xact.cardiac. . Gamma camera cardiac, fast acquired, data is reconstructed by the Xpress.cardiac. The Xact.cardiac & Xpress.cardiac 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.

#### Intended Use of Device

The Xact.cardiac & Xpress.cardiac is 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

#### 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 filter back - projection. No adverse affects have been detected.

#### 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.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized representation of a human figure with three overlapping profiles, suggesting a sense of community and interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and its national scope.

Public Health Service

APR 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Laor QA Manager UltraSPECT Ltd. 30 MATAM, Haifa, 31905 ISRAEL

Re: K050815 Trade/Device Name: WBR Xact.cardiac & Xpress.cardiac Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving communications system Regulatory Class: II Product Code: KPS and LLZ Dated: March 28, 2005 Received: April 6, 2005

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 (Premarket Approval), 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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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 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" (21 CFR 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

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# Indications for Use

510(k) Number (if known):

K05Df/5

Device Name: WBR Xact.cardiac & Xpress.cardiac

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capable of processing and displaying the acquired information in tradition of animated capable of processing and displaying the stigated.
well as in pseudo three dimensional renderings, and in various forms of animated well as in polusion kinetic attributes of the image organs.

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)

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Ylancyi Burgion

(Division Sign Off) Division of Reproductive, Abdominal, and Redictionical Devices 5 It (x) Number _