(30 days)
Not Found
No
The summary describes a digital imaging system with hardware and software for image acquisition and processing, but there is no mention of AI or ML capabilities, image processing is not explicitly mentioned as a key feature, and there is no information about training or test sets typically associated with AI/ML development.
No
The device is described as a digital imaging system for examination and diagnosis, which are diagnostic rather than therapeutic functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that SIDEXIS is intended for "diagnosis of diseases of the teeth, jaw, and oral structures."
No
The device description explicitly states that SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software. It also mentions a new sensor, a new XAB image acquisition board, and a new USB Box, all of which are hardware components.
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.
- SIDEXIS function: SIDEXIS is a digital imaging system that uses X-rays to create images of the teeth, jaw, and oral structures. It is used for radiographic examination and diagnosis based on these images.
- No sample analysis: The description clearly states that SIDEXIS replaces conventional radiographic film and works with digital X-ray sensors. There is no mention of analyzing biological samples.
Therefore, SIDEXIS falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes
90 MUH
Device Description
SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software to be installed into an IBM-compatible personal computer. This Special 510(k) is being submitted to document a new sensor and associated software for digital transverse slice imaging in conjunction with the Orthophos Plus DS / Plus DS Ceph family of digital extraoral source X-ray imaging devices. Other minor modifications discussed in this Special 510(k) include: 1) a new XAB image acquisition board to interface SIDEXIS to the Orthophos X-ray systems via the Ethernet; 2) a new USB (Universal Serial Bus) Box to interface the SIDEXIS with the intraoral sensors; and 3) software enhancements to improve the overall function of SIDEXIS (resulting in software version 5.5).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital X-ray
Anatomical Site
teeth, jaw, and oral structures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
1L0/3459
Special 510(k) Summary
for
SIDEXIS Digital Radiography Imaging System
SPONSOR 1.
DEC 0 6 2001
Sirona Dental Systems GmbH Fabrikstraße 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 3294 Telephone:
November 5, 2001 Date Prepared:
DEVICE NAME 2.
SIDEXIS Digital Radiography Imaging System Proprietary Name: Common/Usual Name: Digital X-ray Imaging System Accessory to Extraoral Source X-ray System Classification Name:
PREDICATE DEVICE 3.
SIDEXIS Digital Radiography System -- K992644
4. INTENDED USE
.
The SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
DEVICE DESCRIPTION હ્
SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software to be installed into an IBM-compatible personal computer. This
November 5, 2001 Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System
Page E-1
1
Special 510(k) is being submitted to document a new sensor and associated software for digital transverse slice imaging in conjunction with the Orthophos Plus DS / Plus DS Ceph family of digital extraoral source X-ray imaging devices. Other minor modifications discussed in this Special 510(k) include: 1) a new XAB image acquisition board to interface SIDEXIS to the Orthophos X-ray systems via the Ethernet; 2) a new USB (Universal Serial Bus) Box to interface the SIDEXIS with the intraoral sensors; and 3) software enhancements to improve the overall function of SIDEXIS (resulting in software version 5.5).
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The SIDEXIS system that is the subject of this 510(k) premarket notification is a modification of SIDEXIS as previously cleared for marketing under K992644. The modified SIDEXIS has the same intended use and principles of operation as the original SIDEXIS, as well as substantially equivalent technical specifications. A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified SIDEXIS Digital Radiography Imaging System.
Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System
November 5, 2001
Page E-2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Sirona Dental Systems, Inc. % Ms. Sheila M. Hemeion-Heyer Medical Device Consultants 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K013659 Trade/Device Name: SIDEXIS Digital Radiography Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: November 5, 2001 Received: November 6, 2001
Dear Ms. Hemeion-Heyer:
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 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, 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 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.
3
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 notification. The I Drice 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 If you desire specific acvies to your as a one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Compilance at (2017 22ation" (21 CFR Part 807.97). Other general information on of felected to premained nothers and the Division of Small Manufacturers, your responsional and Consumer 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,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
Indications For Use:
SIDEXIS is a digital radiography imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elmer A. Sperry
(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System November 5, 2001