(49 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on replacing film with a digital sensor and associated software for image display.
No
The device is intended for diagnosis and examination, not for treating a disease or condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that "THE DXIS® IS INTENDED FOR DENTAL RADIOGRAPHIC EXAMINATION AND DIOGNOSIS OF DISEASES OF THE TEETH, JAW AND ORAL STRUCTURE."
No
The device description explicitly states it consists of a digital x-ray sensor, interface equipment, software, and adapters, indicating it includes hardware components in addition to software.
Based on the provided information, the DXIS® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- DXIS® Function: The DXIS® is a digital x-ray system component used for capturing images of teeth, jaw, and oral structures within the body. It's a medical imaging device, not a device that analyzes biological samples.
The intended use and device description clearly indicate that the DXIS® is for in vivo (within the living body) diagnostic imaging using X-rays.
N/A
Intended Use / Indications for Use
The Signet DXIS® is intended for dental radiographic examination and diagnosis of the teeth, jaw, and oral structure.
Product codes
90 MUH
Device Description
The Signet DXIS® System is designed to replace the film cassettes with a digital sensor in existing dental panoramic x-rav systems that are already on the market. It consists of a digital x-ray sensor. interface equipment, software, and adapters for specific dental x-ray systems. The DXIS® is installed by a Signet authorized technician on existing compatible dental x-ray systems. Software provided by Signet and a user supplied computer permit the images from the digital sensor to be recorded and displayed.
Mentions image processing
YES
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
teeth, jaw, and oral structure
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
510(k) Summarv for DXIS® Digital X-ray Imaging System
510(k) # K983283
1. SPONSOR
Signet Radiology, Inc. 253 Logue Rd. P.O. Box 508 Minto, NB, E0E 1J0 Canada
Contact person: Alex Cetateanu (1)506-327-3931 Telephone:
Date prepared: September 4, 1998
DEVICE NAME 2.
Proprietary Name: Signet DXIS® Direct X-ray Imaging System Common/Usual Name: Digital x-ray imaging system Classification Name: Extra-oral source x-ray system
3. PREDICATE DEVICES
Trophy Digipan (K961826) Siemens Orthophos DS (K972312) Planmeca Dimax (510(k) # not known)
4. DEVICE DESCRIPTION
The Signet DXIS® is intended for dental radiographic examination and diagnosis of the teeth, jaw, and oral structure.
The DXIS® System is designed to replace the film cassettes with a digital sensor in existing dental panoramic x-rav systems that are already on the market. It consists of a digital x-ray sensor. interface equipment, software, and adapters for specific dental x-ray systems. The DXIS® is installed by a Signet authorized technician on existing compatible dental x-ray systems. Software provided by Signet and a user supplied computer permit the images from the digital sensor to be recorded and displayed.
ડ. INTENDED USE
The Signet DXIS® is intended for dental radiographic examination and diagnosis of the teeth, iaw. and oral structure.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIALLY EQUIVALENCE
The DXIS®, like the predicate devices, provides the ability to display, store, or print digital radiographic images of the teeth, jaw or oral structure. A comparison of the DXIS® and the predicate devices is provided in the table given below.
1
| | Comparison | SIGNET
Radiology | TROPHY | PLANMECA | SIEMENS |
|-----|-----------------------------------------|--------------------------------|---------------------------------------|---------------------------------|---------------------------------|
| 1. | Trade Name | DXIS | DigiPan | Planmeca
Dimax | Orthophos
DS |
| 2. | Panoramic Image | YES | YES | YES | YES |
| 3. | X-Ray | YES | YES | YES | YES |
| 4. | Replacement film
cassette | YES | YES | YES | YES |
| 5. | Digital processing | YES | YES | YES | YES |
| 6. | Level of X-ray
Radiation
exposure | Up to 50% | 70% | Information
not
available | Information
not
available |
| 7. | Acquisition sensor | CCD
DXIS
Sensor | CCD
Digital
Cassette | CCD Digital | CCD Array |
| 8. | Panoramic
Acquisition Board | NO | YES | Information
not
available | Information
not
available |
| 9. | Panoramic
Correlator | YES | NO | Information
not
available | Information
not
available |
| 10. | Computer
Interface Board | YES | YES | YES | YES |
| 11. | Acquisition
Software | DXIS
Acquisition
Program | Trophy
Windows
Imaging
(TWI) | Information
not
available | SIDEXIS |
| 12. | Enhancement
functions | YES | YES | YES | YES |
| 13. | Digital storage | YES | YES | YES | YES |
| 14. | Hard copy | YES | YES | YES | YES |
Comparison Table: DXIS® and 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 10008 NOV
Alex Cetateanu President Signet Radiology, Inc. 253 Logue Road P.O. Box 508 Minto, NB. EOE 1J0 Canada
Re:
K983283 Signet DIXS® Direct Dental X-ray Imaging System Dated: September 15, 1998 Received: September 18, 1998 Regulatory class: II 21 CFR 872.1800/Procode: 90 MUH
Dear Mr. Cetateanu:
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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 Register. Please note: this 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 yrity. 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, please note the regulation entitled, "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/odrividsma/dsmamain.html".
Sincerely yours,
Lillian Yip, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal. Ear. Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: DXIS®
Indications For Use:
THE DXIS® IS INTENDED FOR DENTAL RADIOGRAPHIC EXAMINATION AND DIOGNOSIS OF DISEASES OF THE TEETH, JAW AND ORAL STRUCTURE.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Syzon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
Prescription Use X (Per 21 CFR 801.109) Over - The - Counter - Use ___________________________________________________________________________________________________________________________________________________
OR