(12 days)
Not Found
No
The description focuses on standard digital radiography technology and image processing, with no mention of AI, ML, or related concepts.
No.
The device is used for diagnostic imaging, not for treating a condition.
Yes
The device is a digital panoramic device that exposes and acquires radiographic images of the dento-maxillofacial region, processing and displaying the image data. This process of acquiring and presenting anatomical information for review is a key function of diagnostic devices.
No
The device description clearly outlines hardware components such as a high voltage power supply, x-ray tube, digital receptor, and motion stage, indicating it is a physical medical device with integrated software for image processing and display.
Based on the provided information, the CDR PanX Model 4792 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CDR PanX Function: The CDR PanX Model 4792 is an extra-oral dental imaging device. It uses X-rays to create images of the dento-maxillofacial region directly from the patient's body, not from a specimen taken from the body.
The description clearly indicates it's an imaging device used for radiographic exams of the patient's head. This falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.
Product codes (comma separated list FDA assigned to the subject device)
76 MUH
Device Description
The CDR PanX Model 4792 is a digital panoramic device. A high voltage power supply charges an x-ray tube that emits a pulse which is attenuated by the patient's head. An FDA approved digital receptor receives the resultant image and transmits the data to a computer. The receptor and x-ray source both revolve on a motion stage such that multiple projections may be generated thereby resulting in a panoramic view of the skull. The computer processes and displays the image data on a monitor.
Mentions image processing
The computer processes and displays the image data on a monitor.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
dento-maxillofacial region, maxillofacial region, 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
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 radiation survey has confirmed that the device exposes the patient to similar radiation as the predicate. In addition, the device conforms with electrical safety standards and 21CFR 1020.30-31. Schick Technologies has demonstrated through careful analysis and validation studies that the device is substantially equivalent to the already cleared and marketed devices.
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.
Soredex Cranex Tome system
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.
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
§ 872.1800 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
Ko3 1291
MAY - 5 2003
Exhibit IV: 510(k) Summary
Schick CDR PANX MODEL 4792
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: April 10, 2003
A. Legally Marketed Predicate Devices
The Soredex Cranex Tome system is a legally marketed predicate device that emits x-ray radiation for panoramic radiographs. By default, the Soredex system utilizes x-ray film, however a digital receptor that subsequently received clearance under K982661, may also be used with the device. Schick Technologies has now demonstrated equivalence of a new integrated digital panoramic machine to the Soredex system.
B. Device Description
The CDR PanX Model 4792 is a digital panoramic device. A high voltage power supply charges an x-ray tube that emits a pulse which is attenuated by the patient's head. An FDA approved digital receptor receives the resultant image and transmits the data to a computer. The receptor and x-ray source both revolve on a motion stage such that multiple projections may be generated thereby resulting in a panoramic view of the skull. The computer processes and displays the image data on a monitor.
C. Indications for Use
The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.
D. Substantial Equivalence Summary
The CDR PanX Model 4792 is substantially equivalent to digital panoramic units currently marketed in the U.S. The Soredex Cranex Tome is similar in that it is
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indicated for, among other things, panoramic x-ray examinations of the maxillofacial region, although it traditionally utilizes film. It can, however, be retrofit with the CDR – PAN MODEL 4700, which is the same sensor as is utilized in this new integrated product.
E. Testing
A radiation survey has confirmed that the device exposes the patient to similar radiation as the predicate. In addition, the device conforms with electrical safety standards and 21CFR 1020.30-31.
F. Conclusions
Schick Technologies has demonstrated through careful analysis and validation studies that the device is substantially equivalent to the already cleared and marketed devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2003
Schick Technologies % Mr. Donald J. Sherratt Medical Stream Director Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719 Re: K031291
Trade/Device Name: CDR PanX Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II
Product Code: 76 MUH
Dated: April 22, 2003 Received: April 23, 2003
Dear Mr. Sherratt:
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 either class II (Special Controls) or class III (PMA), it may be subject to 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 r 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) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of I Page 1
1163 1291 510(k) Number (if known):_
Device Name:_CDR PanX
Indications For Use:
The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use ✓
Daniel R. Seymm
Sign-Off I Reproductive mner