(90 days)
No
The description focuses on traditional gamma camera technology and image processing software, with no mention of AI or ML.
No
The device is used for imaging and diagnostic purposes (to measure and image the distribution of radioisotopes), not for treating or preventing diseases.
Yes
Explanation: The device is described as measuring and imaging the distribution of radioisotopes in the human body, with the resulting images intended to be reviewed by qualified medical personnel. This process is used to "detect or image the distribution of radionuclides in the body or organ," which aligns with the function of a diagnostic device.
No
The device description clearly outlines multiple hardware components including a Detector Head, Gantry Arm, and Mobile Cabinet, in addition to the software.
Based on the provided information, the Dilon 2000 Digital Gamma Camera 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. They are used to examine these samples outside of the body.
- Dilon 2000 Function: The Dilon 2000 is a gamma camera used to image the distribution of radioisotopes within the human body. It is an in vivo imaging device, meaning it is used to examine the body directly.
The intended use clearly states it's used to "measure and image the distribution of selected single photon emitting radioisotopes in the human body." This is a direct examination of the body, not a test performed on a sample taken from the body.
N/A
Intended Use / Indications for 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.
Indications For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
A. Planar Imaging - Energy Range (keV): 100 to 200
Product codes
90 IYX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma Camera
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical personnel
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Images and performance testing data were collected on a prototype camera. Image quality and camera usage is equivalent to that of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ADAC Transcam (K924639)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1100 Scintillation (gamma) camera.
(a)
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.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows a handwritten date, "3/10/99". The numbers are written in black ink on a white background. The handwriting is somewhat stylized, with the numbers being slightly slanted.
Section E - 510(k) Summary
- General Information .
| A. | Submitted By: | Dilon Technologies Inc.
12050 Jefferson Ave., Suite 250
Newport News, VA 23606
Tel: 757-269-4910
Fax: 757-269-4912 |
|----|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Lee H. Fairchild
Tel: 757-269-4910
Fax: 757-269-4912
Email: lfairchild@dilon.com |
| B. | Device Trade Name:
Common Name:
Classification Name: | Dilon 2000
Gamma Camera System
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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
3
Page 1 of 1
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 | |||
| non Positron emitter | X | ||
| D. Positron imaging by coincidence | X | ||
| E. Positron imaging without coincidence | X | ||
| F. Other indication(s) in the device label, | |||
| but not included in the above list | X |
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sion Sign-Off)
sion of Reproductive, Abdominal, ENT,
ud Radiological Device
k) Number K984466
Prescription Use OR
(Per 21 CFR 801.109)
OR
Over-the-Counter Use