(92 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware modifications for image acquisition, not algorithmic processing.
No
The device is described as an imaging system (Computed Oral Radiology System) that produces digital intraoral x-ray images. Its purpose is diagnosis or image acquisition, not treatment or therapy.
Yes
The device is described as producing intraoral x-ray images of a patient's mouth, which are used for "intra-oral x-ray examinations." X-ray examinations are a diagnostic activity, as they involve imaging to help determine the nature of a condition.
No
The device description explicitly states it is a "small digital imaging receptor" and mentions a "new hardware trigger residing on the CMOS ASIC," indicating it includes physical hardware components.
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.
- Device Function: This device is a Computed Oral Radiology System. It uses x-rays to create images of a patient's mouth directly on the patient. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "intra-oral x-ray examinations" and producing "instant, digital, intraoral x-ray images." This is an imaging procedure performed on the patient, not a diagnostic test performed on a sample.
Therefore, based on the provided information, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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 K041385.
Product codes
MUH, EHD, 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 control mechanism differs from the predicate in that image acquisition is initiated via a new hardware trigger residing on the CMOS ASIC. Direct triggering via an x-ray tube continues to be supported as was cleared in K041385. The modification offers an improvement in system-level support.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
intra-oral, 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K072134
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Exhibit IV: 510(k) Summary
Schick Computed Oral Radiology System ●
NOV - 1 2007
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: Daniel Michaeli, Prepared: October 12, 2007
A. Legally Marketed Predicate Devices
The Computed Oral Radiology System was most recently cleared on June 7, 2004 under K041385. Other prior clearances include 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 control mechanism differs from the predicate in that image acquisition is initiated via a new hardware trigger residing on the CMOS ASIC. Direct triggering via an x-ray tube continues to be supported as was cleared in K041385. The modification offers an improvement in system-level support.
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-rav examinations and indicated for dental patients. It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-rav dosage. This device modification in no way alters the indications for use of this machine beyond what was most recently cleared in K041385.
D. Substantial Equivalence Summary
A risk analysis established the areas of concem. 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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KC72134
Page 2 of 2
E. Conclusions
. . *
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 of the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, with three blue lines forming the head, body, and legs. The text is in a blue sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Daniel Michaeli Director of Scientific Development Schick Technologies, Inc. 30-30 47" Avenue LONG ISLAND CITY NY 11101
AUG 2 3 2013
Re: K072134
Trade/Device Name: Computed Oral Radiology System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD, and MOB Dated: October 15, 2007 Received: October 17, 2007
Dear Mr. Michaeli:
This letter corrects our substantially equivalent letter of November 2. 2007.
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
3
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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Indications for Use
510(k) Number (if known):
Device Name: Computed Oral Radiology System
Indications For Use:
. . ..
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The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a palient's mouth while reducing the necessary x-ray dosage.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tori Whan
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Davices 510(k) Number
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