(54 days)
Not Found
No
The document describes a standard digital X-ray acquisition system and software interface without mentioning any AI/ML components or related performance metrics.
No
The device is described as an acquisition device for digital dental intraoral X-ray exposures, indicating it is for diagnostic imaging, not for treating a disease or condition.
No
Explanation: The device is described as an "acquisition device for digital dental intraoral X-ray exposures." Its purpose is to capture images, not to analyze them or provide a diagnosis. The description mentions managing tasks and interfacing with software, but not interpreting the images for diagnostic purposes.
No
The device description explicitly states it comprises a "XIOSPlus Wall-Module" and "pluggable solid X-ray sensors," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Unit for acquisition of digital dental intraoral X-ray exposures." This describes a device used for capturing images of the inside of the mouth using X-rays.
- Device Description: The description details the components involved in acquiring these X-ray images (wall module, sensors, software plug-in).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens. It is an imaging device.
Therefore, the Sirona XIOSPlus Wall-Module is an imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The XIOSPI48 Wall-Module and the XIOSPlus Sensors are intended for acquisition of digital dental intraoral X-ray exposures.
Unit for acquisition of digital dental intraoral X-ray exposures.
Product codes
MUH
Device Description
The Sirona XIOSPlus Wall-Module is an acquisition device for digital dental intraoral X-ray exposures. It comprises of the XIOSPlus Wall-Module, one or two pluggable solid X-ray sensors and a SIDEXIS Software Plug-in, managing XIOS"108 Wall-Module and Ethernet related tasks, and interfacing SIDEXIS. The XIOS Wall Module is connected via Ethernet to one or more PCs on which the Plug-in and SIDEXIS are running. Operation related information is displayed or signaled through a display or LEDs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
dental intraoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
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510(k) Summary for Sirona Dental Systems XIOSPlus Wall-Module
1. SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 32 94 Telephone:
Date Prepared: August 7, 2008
2. DEVICE NAME
XIOSPlus Wall-Module Proprietary Name: Common/Usual Name: System, X-Ray, Extraoral, Digital Classification Name: Extraoral source x-ray system
3. PREDICATE DEVICE
Sirona Dental Systems Wall-Box K013659 (included in SIDEXIS) and Schick Computed Oral Radiology System K072134.
INTENDED USE 4.
The XIOSPI48 Wall-Module and the XIOSPlus Sensors are intended for acquisition of digital dental intraoral X-ray exposures.
DEVICE DESCRIPTION న్.
The Sirona XIOSPlus Wall-Module is an acquisition device for digital dental intraoral X-ray exposures. It comprises of the XIOSPlus Wall-Module, one or two pluggable solid X-ray sensors and a SIDEXIS Software Plug-in, managing XIOS"108 Wall-Module and Ethernet related tasks, and interfacing SIDEXIS. The XIOS Wall
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Module is connected via Ethernet to one or more PCs on which the Plug-in and SIDEXIS are running. Operation related information is displayed or signaled through a display or LEDs.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The overall design of the Sirona XIOSPlus Wall-Module is similar to the Sirona Wall Box and Schick Intraoral Sensor Imaging System covered in the premarket notification K013659 and K072134 respectively. All devices are for intraoral exposures. All the sensors have similar image areas. The pixel size of the XIOSPlus sensors is identical compared to Schick Intraoral Sensor Imaging System sensors, and smaller compared to the Sirona Wall-Box sensors. The acquired image matrix is higher compared to the Sirona Wall-Box sensors allowing a higher resolution of Xray exposures and identical to the Schick Intraoral sensors. Sirona XIOS Wall-Module and Wall-Box communicate via Ethernet connection with SIDEXIS running on a PC whereas Schick Intraoral Sensor Imaging System communicates via USBconnection. All devices signal their readiness for an exposure. The XIOS "148 Wall-Module device accommodates the connection of two sensors concurrently.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Public Health Service
OCT 28 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sirona Dental Systems GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
Re: K081903
Trade/Device Name: XIOSPlus Wall-Module Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: August 8, 2008 Received: August 11, 2008
Dear Mr. Preiss:
This letter corrects our substantially equivalent letter of August 26, 2008.
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 (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, 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 (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
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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 continue 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 (240) 276-0120. 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Joyce M. Whang, Ph.D.
Image /page/3/Picture/5 description: The image shows the handwritten word "for" in cursive. The word is written in black ink on a white background. The letters are connected and flow smoothly together.
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
XIQS 1115 Wall-Module Device Name: ____
Indications for Use:
Unit for acquisition of digital dental intraoral X-ray exposures.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 08/903 510(k) Number
Sirona Dental Systems 510(k) XIOSPlus Wall-Module
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