MODIFICATION TO WBR, MODEL HR

K031874 · U.C.G. Technologies , Ltd. · KPS · Jul 18, 2003 · Radiology

Device Facts

• Record ID: K031874
• Device Name: MODIFICATION TO WBR, MODEL HR
• Applicant: U.C.G. Technologies , Ltd.
• Product Code: KPS · Radiology
• Decision Date: Jul 18, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The WBR- WB 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.

Device Story

WBR-WB is an image processing system interfaced with gamma cameras; it acquires, processes, stores, and displays scintigraphy data. The system transforms raw camera output into high-resolution images, pseudo 3D renderings, and animated sequences representing organ kinetics. Used in clinical settings, the device allows healthcare providers to view processed images via DICOM or Interfile-compatible PACS. By enhancing image resolution compared to unprocessed data, the device assists clinicians in diagnostic interpretation and clinical decision-making.

Clinical Evidence

Bench and clinical data provided. Testing demonstrated that processed images exhibit equivalent or superior resolution compared to unprocessed images. No adverse effects were reported.

Technological Characteristics

Image processing system for gamma camera output. Connectivity via DICOM or Interfile-compatible PACS. Software-based image enhancement and rendering.

Indications for Use

Indicated for the acquisition, formatting, and storage of scintigraphy camera output data, including processing and display in traditional formats, pseudo three-dimensional renderings, and animated sequences showing kinetic attributes of image organs.

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

• WBR-HR (K030870)

Submission Summary (Full Text)

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Ko31874

# JUL 18 2003

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

#### Device Name

.

Proprietary Device Name : WBR -WB.

# 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 Radiology Image processing (per 21CFR 892.1200) Imaging system Class II Product

### Reason for 510(k) Submission

Simplified 510(k) Submission

### Identification of Legally Marketed Equivalent Devices K030870 WBR-HR

#### Device Description

The WBR - WB is an image processing system, which is interfaced to gamma cameras. The camera-acquired data is processed by the WBR - WB, which 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- WB 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 processed images are equivalent or of better resolution comparing to the un - processed images. No adverse affects have been detected.

#### Substential Equivalency

It is U.C.G. opinion that the WBR- WB is substantially equivalent in terms of safety and effectiveness to the predicate device.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Laor Quality Manager U.C.G. Technologies, Ltd. P.O. Box 15010, MATAM Haifa, 31905 ISRAEL

JUL 1 8 2003

Re: K031874 Trade/Device Name: WBR-WB Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: June 12, 2003 Received: June 25, 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. Iisting 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 vours.

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): DEVICE NAME: WBR - WB

K03/874

DEVICE NAME: WBR - WB

INDICATION FOR USE: The WBR- WB 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
(Per 21 CFR 801.109) OR Over-the-Counter Use **__**

(Division Sign-Off)
Division of Reproductive, Abdominal,

and Radiological D 510(k) Number