(53 days)
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No
The provided text describes a standard digital X-ray system and does not mention any AI or ML capabilities, image processing beyond basic X-ray capture, or performance studies related to algorithmic analysis.
No
The device is an X-ray system used for diagnostic imaging, not for treating any condition.
Yes
The device is indicated for "diagnostic examination of dentition (teeth), jaws and oral structures" and "cephalometric examination," which are diagnostic activities.
No
The device is described as an "extra-oral X-ray system," which inherently includes hardware components for generating and capturing X-ray images. The description of producing panoramic and cephalometric images further confirms it is a physical imaging system, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the hyperion is to produce X-ray images of the maxillofacial area, jaws, and parts of the skull. This is a direct imaging technique of the patient's anatomy, not the analysis of a biological sample.
- The description focuses on imaging capabilities. The intended use and anatomical site clearly indicate that this is an imaging device used for diagnostic purposes based on the visual information from the X-ray images.
Therefore, the hyperion is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
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Intended Use / Indications for Use
The hyperion is a digital panoramic and cephalometric extra-oral X-ray system, indicated for use in:
- producing panoramic X-ray images of the maxillofacial area, for (i) diagnostic examination of dentition (teeth), jaws and oral structures; and
- · producing radiographs of the jaws and parts of the skull, for the (ii) purpose of cephalometric examination if equipped with CEPH arm.
Product codes
MUH, MQB
Device Description
The hyperion is a digital panoramic and cephalometric extra-oral X-ray system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
maxillofacial area, dentition (teeth), jaws, oral structures, parts of the skull
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's seal and the agency's symbol. The seal is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The agency's symbol is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of the nation.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Cefla S.C. Cefla Dental Group % Mr. William Sammons Senior Project Manager - Medical Devices Intertek Testing Services NA, Inc. 2307 E Aurora Road, Unit B7 TWINSBURG OH 44087
JAN 1 7 2012
Re: K113497
Trade/Device Name: hyperion Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH & MQB Dated: January 3, 2011 Received: January 4, 2011
Dear Mr. Sammons:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements us a 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: hyperion
Indications for Use:
The hyperion is a digital panoramic and cephalometric extra-oral X-ray system, indicated for use in:
- producing panoramic X-ray images of the maxillofacial area, for (i) diagnostic examination of dentition (teeth), jaws and oral structures; and
- · producing radiographs of the jaws and parts of the skull, for the (ii) purpose of cephalometric examination if equipped with CEPH arm.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Patil
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113497