DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5

K984466 · Dilon Technologies, Inc. · IYX · Mar 16, 1999 · Radiology

Device Facts

• Record ID: K984466
• Device Name: DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
• Applicant: Dilon Technologies, Inc.
• Product Code: IYX · Radiology
• Decision Date: Mar 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1100
• Device Class: Class 1

Intended Use

The Dilon 2000 Digital Gamma Camera is intended to be used to measure and image the distribution of selected single photon emitting radioisotopes in the human body. The resulting images are intended to be reviewed by qualified medical personnel.

Device Story

Dilon 2000 is a portable, small field-of-view gamma camera for planar nuclear medicine imaging. Input: gamma radiation from radioisotopes in human body. Detector head uses scintillation crystal array and position-sensitive photomultiplier tubes to convert radiation to electrical signals. Signal amplification and discrimination electronics process inputs; Segami Pegasus software performs image development. Output: planar images displayed for review by qualified medical personnel. Operated by technologists in clinical settings; gantry arm provides positioning. Images assist clinicians in diagnosing distribution of radioisotopes, aiding clinical decision-making regarding organ function or pathology.

Clinical Evidence

Bench testing only. Performance data and image quality were collected on a prototype camera and compared to the predicate device to demonstrate equivalence.

Technological Characteristics

Portable gamma camera; detector head with scintillation crystal array and position-sensitive photomultiplier tubes; gantry arm with counter-balancing; mobile cabinet with data acquisition electronics and high voltage power supply. Energy range: 100-200 keV. Software: Segami Pegasus imaging software. Connectivity: standalone system.

Indications for Use

Indicated for planar imaging of single photon emitting radioisotopes in the human body or organs, within an energy range of 100 to 200 keV. For use by qualified medical personnel.

Regulatory Classification

Identification

A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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

• ADAC Transcam (K924639)

Submission Summary (Full Text)

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K984466

# Section E - 510(k) Summary

- General Information .

| A. | Submitted By: | Dilon Technologies Inc.<br>12050 Jefferson Ave., Suite 250<br>Newport News, VA 23606<br>Tel: [phone]<br>Fax: [phone] |
|----|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Lee H. Fairchild<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| B. | Device Trade Name:<br>Common Name:<br>Classification Name: | <i>Dilon 2000</i><br>Gamma Camera System<br>Scintillation (Gamma) Camera |
| C. | Predicate Devices: | ADAC Transcam (K924639) |
| D. | Device Description: | |

The Dilon 2000 is a high resolution, small field of view, portable gamma camera designed for general use in imaging radio pharmaceuticals.

The primary components of the Dilon 2000 are:

Detector Head: contains a two dimensional array of scintillation crystals, an array of position sensitive photomultiplier tubes and signal amplification and discrimination electronics.

Gantry Arm: safely supports the detector as positioned by the technologist operating the camera. Counter balancing is provided to hold the detector in its last position.

Mobile Cabinet: Contains data acquisition electronics, image development computer and Segami Pegasus™ imaging software. The cabinet also contains power filtering, isolation and a high voltage power supply.

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#### D. Intended Use:

The Dilon 2000 Digital Gamma Camera is intended to be used to measure and image the distribution of selected single photon emitting radioisotopes in the human body. The resulting images are intended to be reviewed by qualified medical personnel.

- E. Substantial Equivalence:
The Dilon 2000 has the same indications for use as the predicate gamma cameras and employs equivalent gamma detection technology.

#### II. Testing

Images and performance testing data were collected on a prototype camera. Image quality and camera usage is equivalent to that of the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1999

Lee H. Fairchild Director of Product Marketing Dilon Technologies Inc. Applied Research Center 12050 Jefferson Ave., Suite 250 Newport News, VA 23606

Re:

K984466 Dilon 2000 Gamma Camera Dated: December 14, 1998 Received: December 16, 1998 Regulatory class: I 21 CFR 892.1100/Procode: 90 IYX

Dear Mr. Fairchild:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally acturined the devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the manced production as noo more with the been reclassified in accordance with the provisions of the Mourdines Annoneneric Act (Act). 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 if your device is dazence (oo above) institutions affecting your device can be found in the Code of be days to udalland Controls. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal regarding action. In addition, response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, the promotes and and which the titled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal. Ear. Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): K984466 Device Name: Dilon 2000

## Nuclear Medicine Devices

Indications For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).

| | YES | NO | Energy Range (keV) |
|-----------------------------------------------------------------------------------|-----|----|--------------------|
| A. Planar Imaging | X | | 100 to 200 |
| B. Whole body imaging | | X | |
| C. Tomographic imaging (SPECT) for<br>non Positron emitter | | X | |
| D. Positron imaging by coincidence | | X | |
| E. Positron imaging without coincidence | | X | |
| F. Other indication(s) in the device label,<br>but not included in the above list | | X | |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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sion of Reproductive, Abdominal, ENT,
ud Radiological Device
k) Number K984466

Prescription Use OR

(Per 21 CFR 801.109)

OR

Over-the-Counter Use