WBR, MODEL HR

K030870 · U.C.G. Technologies , Ltd. · KPS · Apr 9, 2003 · Radiology

Device Facts

• Record ID: K030870
• Device Name: WBR, MODEL HR
• Applicant: U.C.G. Technologies , Ltd.
• Product Code: KPS · Radiology
• Decision Date: Apr 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended 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.

Device Story

WBR-HR is an image processing system interfaced with gamma cameras; acquires scintigraphy camera output data; reconstructs images using parallel and non-parallel beams; produces high-resolution images, pseudo 3D renderings, and animated sequences of organ kinetics. Used in clinical settings; operated by medical staff. Output transferred to DICOM or Interfile-compatible PACS for physician review and clinical decision-making. Benefits include enhanced image resolution compared to predicate systems.

Clinical Evidence

Bench and clinical data provided. Comparison of reconstructed images against predicate device demonstrated equivalent or better resolution. No adverse effects detected.

Technological Characteristics

Image processing system for gamma cameras; utilizes parallel and non-parallel beam reconstruction algorithms; supports DICOM and Interfile connectivity; software-based image processing.

Indications for Use

Indicated for acquisition, formatting, storage, processing, and display of scintigraphy camera output data, including pseudo 3D renderings and animated sequences of organ kinetic attributes.

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 system (K972886)

Submission Summary (Full Text)

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# 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.

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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.

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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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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510(k) Number (if known):

K030870

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 | <div style="text-align:left;"> ✓ </div> |
|----------------------|---------------------------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR Over-the-Counter Use

| (Division Sign-Off) | <div style="text-align:left;"> Nancy C. Brogdon </div> |
|-----------------------------------------------------------|------------------------------------------------------------------------------------|
| Division of Reproductive, Abdominal, Radiological Devices | |
| 510(k) Number | K030800 |