(88 days)
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No
The summary describes a standard digital radiography system and does not mention any AI or ML components or capabilities.
No
Explanation: The device is indicated for "dental radiographic examination and diagnosis," which are diagnostic purposes, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" states the system is intended for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures," which clearly indicates a diagnostic purpose.
No
The device description explicitly states it consists of a "digital sensor" and "image display," 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 clearly states that the system is used for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." This involves imaging the internal structures of the body using X-rays.
- Device Description: The device consists of a "digital sensor" and "image display," which are components of an imaging system, not a system designed to test samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose disease. IVDs are specifically designed for in vitro (outside the body) examination of specimens.
This device falls under the category of a medical imaging device, specifically a digital radiography system for dental use.
N/A
Intended Use / Indications for Use
The SIDEXIS Digital Radiography System consisting of digital sensor, image I he StDEXAS DEgitar Natiogradisplay is indicated to replace conventional radiographic film when used with extraoral source X-ray systems which are intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes
90 EHD
Device Description
SIDEXIS Digital Radiography System consisting of digital sensor, image display.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and oral structures
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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Image /page/0/Picture/0 description: The image shows a partial view of a logo and some text. The logo features a stylized design with three curved lines resembling a wing or a symbol. To the left of the logo, there is text arranged in a circular pattern, with the words "HEALTH & HUM" visible. To the right of the logo, the letters "DEP" are visible.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 1997
Steven A. Clarke, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street - . . . . . . . . . . . North Attleboro, MA 02760
Re:
K972168 SIDEXIS Digital Radiography System Dated: June 6, 1997 Received: June 9, 1997 Regulatory class: II 21 CFR 892.1800/Procode: 90 EHD
Dear Mr. Clarke:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, subject to the general controls provisions of 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begine your device as described in your 5100k) prematies 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincercly yours
h. Lillian Yin, Ph.D.
Director. Division of Reproductive. Abdominal, Ear. Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known):
Device Name: _ SIDEXIS Digital Radiography System_
Indications For Use:
The SIDEXIS Digital Radiography System consisting of digital sensor, image I he StDEXAS DEgitar Natiogradisplay is indicated to replace conventional radiographic film when used with extraoral source X-ray systems which are intended 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)
Thorn A. Heyman
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
Prescription Use (Per 21 CFR 801.109) (){{
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________