(444 days)
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No
The summary mentions "image processing" but does not include any terms or descriptions indicative of AI/ML, such as "AI," "ML," "deep learning," "neural network," or details about training/test sets or performance metrics typically associated with AI/ML models.
No
The device is described as an "image acquisition and management system" for dental images, which focuses on acquiring, processing, displaying, and printing images. It does not mention any therapeutic function or the ability to treat a condition.
No
This device is an "image acquisition and management system" that allows for the acquisition, processing, display, and print of radiographs and/or color dental images. It does not perform analysis or provide interpretations for diagnosis; it primarily handles the imaging data.
No
The device description explicitly mentions hardware components like a standard S-video color camera and a Charge Injection Device (CID) sensor for image acquisition, in addition to the software for image management.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The InfiMed Dental System is an image acquisition and management system for dental radiographs and color dental images. It deals with visual information from within the mouth, not with analyzing biological samples.
- Intended Use: The intended use clearly states it's for acquiring, processing, displaying, and printing dental images. This is related to imaging and visualization, not laboratory testing of biological specimens.
The information provided describes a medical imaging device used in a dental setting, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information.
Product codes (comma separated list FDA assigned to the subject device)
90 EHD
Device Description
Its capabilities include: Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a Charge Injection Device (CID) sensor custom designed for the application. Images can be directly printed and displayed on standard S-video equipment or transferred to a personal computer for acquisition and storage. If images are stored on the personal computer, dental image management software is utilized for patient data input, image processing, and image display on the computer monitor. In addition, printed reports are available from the personal computer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Radiographs, Color dental images (from S-video color camera)
Anatomical Site
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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.
0
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 11 1997
Morteza Minace Manager Quality Assurance InfiMed, Inc. 121 Metropolitan Drive Liverpool, New York 13088 Re:
K962422 InfiMed Dental System Dated: July 31, 1997 Received: August 1, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Minace:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decermined the vice is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce or to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registerion, 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 Coatrols) or class III (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the Goff regulation may result in regulatory action. In addition, FDA may publish fiurther announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 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 predication 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 yitro diamostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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"
Sincerely yours,
H.T.Liau Yu
Lillian Yin, Ph.D.
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
Page 1 of 1
510(k) Number (if known): K962422
Device Name: InfiMed Dental System
Indications for Use:
The InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information.
Its capabilities include:
Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a Charge Injection Device (CID) seasor custom designed for the application. Images can be directly printed and displayed on standard S-video equipment or transferred to a personal computer for acquisition and storage. If images are stored on the personal computer, dental image management software is utilized for patient data input, image processing, and image display on the computer monitor. In addition, printed reports are available from the personal computer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NERDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_$\mathbb{X}$ OR Over-the-Counter Use _
of the image is: Prescription Use_$\mathbb{X}$ OR Over-the-Counter Use _
the OCR of the image is: Prescription Use_$\mathbb{X}$ OR Over-the-Counter Use _
OTC. the Contact Coe.
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
David be Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number