(120 days)
Not Found.
Not Found.
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is described as producing X-ray images for diagnostic support, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the device is intended "as diagnostic support."
No
The device description is not found, but the intended use clearly describes a device that produces X-ray images, which requires hardware (an X-ray machine). Therefore, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device produces X-ray images of the dentomaxillofacial region, hand, and wrist. This is an in vivo imaging technique, meaning it examines the body directly, not specimens taken from the body.
- Intended Use: The intended use is to provide diagnostic support through imaging, not through the analysis of biological samples.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CS 8100SC and the CS 8100SC Access are intended to produce complete or segmented tomographic digital panoramic and cephalometric digital X-ray images to be used at the direction of healthcare professionals of the dentomaxillofacial region of the human anatomy as diagnostic support for pediatric and adult patients. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
In addition, the CS 8100SC is provided with the panoramic radiological exam option which allows the display of one determined segment of the dental structures using the capability of the system to explore each slice during an exam.
Product codes
MUH
Device Description
Not Found.
Mentions image processing
Not Found.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
X-Ray
Anatomical Site
dentomaxillofacial region, hand and wrist
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare professionals
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.
Not Found.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
Trophy % Marie-Pierre Labat-Camy Regulatory Affairs Manager 4 Rue F. Pelloutier Croissy-beaubourg, 77435 FR
Re: K151087
Trade/Device Name: Cs 8100sc. Cs8100sc Access Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: April 20, 2015 Received: April 24, 2015
Dear Marie-Pierre Labat-Camy:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara For
Robert Ochs Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151087
Device Name
CS 8100SC and CS 8100SC Access
Indications for Use (Describe)
The CS 8100SC and the CS 8100SC Access are intended to produce complete or segmented tomographic digital panoramic and cephalometric digital X-ray images to be used at the direction of healthcare professionals of the dentomaxillofacial region of the human anatomy as diagnostic support for pediatric and adult patients. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
In addition, the CS 8100SC is provided with the panoramic radiological exam option which allows the display of one determined segment of the dental structures using the capability of the system to explore each slice during an exam.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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