(58 days)
Not Found
No
The summary describes a digital x-ray imaging device intended to replace film, focusing on image acquisition and compliance with safety and software standards. There is no mention of AI, ML, or any related technologies for image processing or analysis.
No
The device is indicated for individuals requiring extra-oral dental examinations and is used for acquiring diagnostic cephalometric x-ray images, which are used for diagnosis and monitoring, not for therapy.
Yes
The device is described as acquiring "diagnostic cephalometric x-ray images of the skull," which are used to measure skeletal changes and monitor oral growth and development, indicating a diagnostic function.
No
The device description explicitly states that the device is bundled with a specialized collimator and positioning elements, which are hardware components. It is not solely software.
Based on the provided information, the Ceph Model 4900 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.
- Ceph Model 4900 Function: The Ceph Model 4900 is a device used to acquire extra-oral x-ray images of the skull. It replaces traditional x-ray film in this process.
- Nature of the Examination: The examination is performed directly on the patient's body using an imaging modality (X-ray). It does not involve analyzing samples taken from the body.
Therefore, the Ceph Model 4900 falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Ceph Model 4900 is indicated for individuals who require extra-oral dental radiographic examinations.
Product codes
MUH
Device Description
The Ceph Model 4900 is intended to replace x-ray film in the acquisition of diagnostic cephalometric x-ray images of the skull as are commonly used in orthodontics to measure skeletal changes and monitor oral growth and development. The device works with a cleared x-ray device, along with a specialized collimator and positioning elements that are bundled together and sold as the PanCeph system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The device has been tested to comply with applicable electrical safety standards required for CE marking. It also complies with FDA documents "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". A radiation survey has confirmed that the system, when used with the generator, imparts similar scatter, and less dose as compared to the film predicate.
Key Metrics
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.
0
K05-3558
FEB 1 7 2006
Exhibit IV: 510(k) Summary
Schick Ceph Model 4900
Common/Classification Name: "DIGITAL X-RAY EXTRAORAL SOURCE SYSTEM" 21CFR872.1800
Schick Technologies, Inc. 30-00 47th Avenue Long Island City, NY 11101 718-937-5765, 718-937-5962 (FAX) Contact: Daniel Michaeli, Prepared: December 1, 2005
A. Legally Marketed Predicate Devices
KODAK T-MAT G FILM SO-381 (K837506) is a legally marketed predicate receptor that is indicated for cephalometric examinations. The CDR PANX, MODEL 4792 (K031291) is a legally marketed predicate x-ray generator indicated for extra-oral dental exams, and will be utilized as the host generator on the Ceph Model 4900. The integrated software is similar to that utilized in the COMPUTED ORAL RADIOLOGY SYSTEM (K041385).
B. Device Description
The Ceph Model 4900 is intended to replace x-ray film in the acquisition of diagnostic cephalometric x-ray images of the skull as are commonly used in orthodontics to measure skeletal changes and monitor oral growth and development. The device works with a cleared x-ray device, along with a specialized collimator and positioning elements that are bundled together and sold as the PanCeph system.
C. Indications for Use
Ceph Model 4900 is indicated for individuals who require extra-oral dental radiographic examinations.
D. Substantial Equivalence Summary
The Ceph Model 4900 has the similar indications for use and is substantially equivalent to other cephalometric units currently marketed in the U.S (e.g. K837506). The already cleared CDR PANX, MODEL 4792 will be utilized as the
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extra-oral generator for this device. The device utilizes substantially equivalent software to the COMPUTED ORAL RADIOLOGY SYSTEM.
E. Testing
The device has been tested to comply with applicable electrical safety standards required for CE marking. It also complies with FDA documents "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". A radiation survey has confirmed that the system, when used with the generator, imparts similar scatter, and less dose as compared to the film predicate.
F. Conclusions
Schick Technologies has demonstrated through careful analysis and validation studies that the device is substantially equivalent to the already cleared and marketed device.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
FEB 1 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Schick Technologies, Inc. % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K053558
Trade/Device Name: Ceph Model 4900 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 2, 2006 Received: February 3, 2006
Dear Mr. Lehtonen:
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 do increative apperal controls provisions of the Act. The general controls provisions of the Act de nee, sayer to not go and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (2) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) Fills tetter with anow you to organization of substantial equivalence of your device to a legally premative notification: "The 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), please If you desire specific at nee for your de rest the following numbers, based on the regulation number at the top of this letter:
| 21 CFR | ||
|---|---|---|
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 007.77). Tou may ootan outer gational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely yours.
Nancy C. Brigdon
Nancy (). Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K05-3558
Device Name: Ceph Model 4900
Indications For Use:
The Ceph Model 4900 is indicated for individuals requiring extra-oral dental examinations.
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)
David B. Hunnem
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
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