(25 days)
Not Found
No
The summary focuses on hardware modifications (scintillation material) for improved image quality and does not mention any software or algorithmic components related to AI or ML.
No
The device is used for diagnostic imaging (intra-oral x-ray examinations) to produce images. It does not provide any therapy or treatment.
Yes
The device is described as producing intra-oral x-ray images, which are used by healthcare professionals to diagnose conditions within a patient's mouth.
No
The device description explicitly states it is a "small digital imaging receptor" and mentions a "new scintillation material," indicating it is a physical hardware component used in place of dental x-ray film.
No, 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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Computed Oral Radiology System is an imaging device that uses X-rays to create images of a patient's mouth. It directly interacts with the patient's body (via the X-ray beam) and does not analyze samples taken from the body.
- Intended Use: The intended use is for "intra-oral x-ray examinations" and producing "digital, intraoral x-ray images." This is a diagnostic imaging function, not an in vitro diagnostic function.
The device is a medical imaging device used for diagnostic purposes, but it falls under the category of radiological imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The Computed Oral Radiography System is intended for intra-oral x-ray examinations and indicated for dental patients. It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-ray dosage. This device modification in no way alters the indications for use of this machine beyond what was most recently cleared in K072134.
The Computed Oral Radiography System is indicated for patients undergoing an intra-oral dental X-ray examination. It produces instant digital intra-oral X-ray images of a patient's mouth.
Product codes (comma separated list FDA assigned to the subject device)
EAP, MOB
Device Description
The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. A new scintillation material differs from the predicate in that in that it affords higher resolution and lower noise. Direct triggering via an x-ray tube continues to be supported as was cleared in K072134 and K041385. The modification offers an improvement in image quality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Intra-oral / patient's mouth
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)
A risk analysis established the areas of concern. The principal risk is unintended x-ray exposure. These areas have been evaluated following imaging, software validation, and third-party safety testing. All validation activities have demonstrated that the predetermined acceptance criteria were met.
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.
K072134, K041385, K022953, K933455
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
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically 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 inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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Exhibit IV: 510(k) Summary ·
Schick Computed Oral Radiology System
NOV 3 0 2009
Common/Classification Name: Solid State X-ray Imager 21 CFR892.1650
Schick Technologies, Inc. 30-30 47th Avenue Long Island City, NY 11101 718-937-5765, 718-937-5962 (FAX) Contact: Howard Fidel, Prepared: November 20, 2009
A. Legally Marketed Predicate Devices
The Computed Oral Radiology System was most recently cleared on November 2, 2007 under K072134. Other prior clearances include K041385, K022953 and K933455. The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film.
B. Modification Description
A new scintillation material differs from the predicate in that in that it affords higher resolution and lower noise. Direct triggering via an x-ray tube continues to be supported as was cleared in K072134 and K041385. The modification offers an improvement in image quality.
The modification in no way alters the fundamental technology nor intended use.
C. Intended Use
The Computed Oral Radiology System is intended for intra-oral x-ray examinations and indicated for dental patients. It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-ray dosage. This device modification in no way alters the indications for use of this machine beyond what was most recently cleared in K072134.
D. Substantial Equivalence Summary
A risk analysis established the areas of concern. The principal risk is unintended x-ray exposure. These areas have been evaluated following imaging, software validation, and third-party safety testing. All validation activities have demonstrated that the predetermined acceptance criteria were met. Where appropriate, warnings have been incorporated within the user manual.
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E. Conclusions
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Schick Technologies has demonstrated through a risk analysis and validation studies that the device modification is substantially equivalent to the already cleared and marketed device.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue. The text is positioned to the right of the eagle symbol. The logo is simple and professional in appearance.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Howard Fidel, MS Project Manager Schick Technologies, Inc. 30-30 47th Avenue LONG ISLAND CITY NY 11101
AUG 23 2013
Re: K093453
Trade/Device Name: Computed Oral Radiology System Regulation Number: 21 CFR 892.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP and MOB Dated: November 3, 2009 Received: November 5. 2009
Dear Mr. Fidel:
This letter corrects our substantially equivalent letter of November 30. 2009.
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 of
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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 will allow you to 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,
Janine M. Morris
Acting 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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Exhibit III: Indications for Use
Indications for Use Form
510(k) Number: K093453
Device Name: Computed Oral Radiography System
Indications for Use:
The Computed Oral Radiography System is indicated for patients undergoing an intra-oral dental X-ray examination. It produces instant digital intra-oral X-ray images of a patient's mouth.
Prescription Use (Part 21 CFR 801 Subpan D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
i
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093453