(15 days)
No
The document describes standard digital radiography technology and image processing features, but there is no mention of AI or ML.
No
The device is used to collect and display dental x-ray images for diagnostic use, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system's output (electronic impulses) "may be stored, viewed, and manipulated for diagnostic use by dentists." This indicates its role in the diagnostic process.
No
The device description explicitly states that the system consists of hardware components including an electronic sensor, a USB electronics box, and associated cables, in addition to software.
Based on the provided information, this device 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.
- Device Function: The SuniRay II Digital Radiography System is used to capture dental X-ray images. It works by converting X-ray photons into electronic signals for viewing and manipulation. This is an in vivo process (occurring within the living body), not an in vitro process (occurring outside the body).
- Intended Use: The intended use is for diagnostic use by dentists based on the captured X-ray images, which are direct representations of the patient's anatomy.
Therefore, the device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SuniRay II Digital Radiography System is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The Suni SuniRay II Digital Radiography System ("System") will produce real time digital intra-oral images with a reduction in X-ray dosages as compared to film. The System accomplishes this by replacing X-ray film with an electronic sensor that captures the X-ray photons and converts the photons to an electronic signal which in turn is captured in a computer for viewing, manipulating, storing, and outputting (printing or Email).
The System consists of two sensor versions (designated as #1 & #2 sizes; equivalent to dental film sizes), an attached USB electronics box that controls the sensor and interfaces to the computer USB port. The System also includes software drivers that control the USB electronics box, and a Graphical User Interface (GUI) that allows the user access to the data and control functions of the System.
The GUI used with the device was designed by Apteryx, Inc. who holds 510(k) K983111 for their product. Apteryx is responsible for both product validation and GMP compliance. The SuniRay II System software utilizes the Windows XP environment.
The System sensors are in two formats. The #2 size is a larger sensor typical of the European format and the # 1 size is an intermediate size. The sensors consist of a CMOS type integrated circuit, and a high resolution scintillator screen that converts the photons from the X-rays into visible light, which is then acquired by the CMOS imaging integrated circuit. The sensors are encapsulated with a three-foot cable that is connected to the USB electronics box.
The USB electronics box plugs into a computer USB port via a supplied USB cable. The USB electronics box contains the support and control circuitry for the sensor and allows for data communications with the computer. The USB electronics box contains all necessary circuits for sensor data acquisition as well as memory for firmware control of the CMOS X-ray sensor and USB. The USB electronics box communicates with the computer under control of a specific device driver that is active with the GUI.
The System software functions on three levels: (1) The computer operating system (Microsoft Windows) controls the computer, user interface, and file structure; (2) Primary control of the sensor and bus functions is achieved by proprietary software and is either embedded firmware or in non user accessible drivers; and (3) A Graphical User Interface (GUI) allows the user to control the x-ray function, control of the sensor data acquisition, and image viewing, manipulation and output. Examples of the GUI include image capture, enhanced viewing features (zoom, pan, colorize, contrast/brightness, comparative analysis, etc) image organization, and storage.
The System meets the requirements of EN 60601 for safety and electromagnetic compatibility. For this Pre-Market Notification, similarities and changes made to this System from the predicate are summarized in Section 8.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Suni Medical Imaging, Inc. - Pre-Market Notification for the SuniRay II Digital Radiography System - 1/5/2007
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
Trade Name Classification Name Common Name
....
SuniRay II Digital Radiography System Digital Extraoral Source X-Ray System Digital X-Ray
7 2007 EEB
Classification
Device Panel Procode Reference
Class II Radiology MUH 21 CFR 872.1800
Registration Number
3003952803
Sponsor Name and Address
Suni Medical Imaging, Inc. 6840 Via Del Oro San Jose, CA 95119
Manufacturer Name and Address
Suni Medical Imaging, Inc. 6840 Via Del Oro San Jose, CA 95119
Reason for Pre-Market Notification
New design
Equivalent Legally Marketed Device
Suni Intraoral Imaging System
Indications for Use:
The SuniRay II Digital Radiography System is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
1
510(k) Summary of Safety and Effectiveness
The Suni SuniRay II Digital Radiography System ("System") will produce real time digital intra-oral images with a reduction in X-ray dosages as compared to film. The System accomplishes this by replacing X-ray film with an electronic sensor that captures the X-ray photons and converts the photons to an electronic signal which in turn is captured in a computer for viewing, manipulating, storing, and outputting (printing or Email).
The System consists of two sensor versions (designated as #1 & #2 sizes; equivalent to dental film sizes), an attached USB electronics box that controls the sensor and interfaces to the computer USB port. The System also includes software drivers that control the USB electronics box, and a Graphical User Interface (GUI) that allows the user access to the data and control functions of the System.
The GUI used with the device was designed by Apteryx, Inc. who holds 510(k) K983111 for their product. Apteryx is responsible for both product validation and GMP compliance. The SuniRay II System software utilizes the Windows XP environment.
The System sensors are in two formats. The #2 size is a larger sensor typical of the European format and the # 1 size is an intermediate size. The sensors consist of a CMOS type integrated circuit, and a high resolution scintillator screen that converts the photons from the X-rays into visible light, which is then acquired by the CMOS imaging integrated circuit. The sensors are encapsulated with a three-foot cable that is connected to the USB electronics box.
The USB electronics box plugs into a computer USB port via a supplied USB cable. The USB electronics box contains the support and control circuitry for the sensor and allows for data communications with the computer. The USB electronics box contains all necessary circuits for sensor data acquisition as well as memory for firmware control of the CMOS X-ray sensor and USB. The USB electronics box communicates with the computer under control of a specific device driver that is active with the GUI.
The System software functions on three levels: (1) The computer operating system (Microsoft Windows) controls the computer, user interface, and file structure; (2) Primary control of the sensor and bus functions is achieved by proprietary software and is either embedded firmware or in non user accessible drivers; and (3) A Graphical User Interface (GUI) allows the user to control the x-ray function, control of the sensor data acquisition, and image viewing, manipulation and output. Examples of the GUI include image capture, enhanced viewing features (zoom, pan, colorize, contrast/brightness, comparative analysis, etc) image organization, and storage.
The System meets the requirements of EN 60601 for safety and electromagnetic compatibility. For this Pre-Market Notification, similarities and changes made to this System from the predicate are summarized in Section 8.
2
Image /page/2/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. Inside the circle is a stylized graphic of three human figures connected at the hands, forming a chain-like shape. The figures are abstract and represented by curved lines, giving the impression of movement and connection. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Suni Medical Imaging, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131
7 2007
Re: K070219
Trade/Device Name: SuniRay II Digital Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system
Regulation Name: Extraoral source x-ray system
Regulatory Class: II Product Code: MUH Dated: January 19, 2007 Received: January 23, 2007
Dear Mr. Christensen:
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 American in microade of the 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/12 description: The image shows a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906-1996" are displayed. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
3
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C Hodgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Suni Medical Imaging, Inc. – Pre-Market Notification for the SuniRay II Digital Radiography System – 1/5/2007
Indications for Use
510(k) Number (if known): Hot assigned K070217
Device Name: SuniRay II Digital Radiography System
...
Indications for Use:
The SuniRay II Digital Radiography System is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Szymanski
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 070219 510(k) Number
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