(134 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related terms, and the device description is not available to provide further clues.
No
The device is used for acquiring radiographic images for diagnostic procedures, not for treating or preventing a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device "is intended to replace radiographic film/screen systems in panoramic dental diagnostic procedures," explicitly mentioning "diagnostic procedures."
No
The summary describes a "Panoramic Dental Digital Imager" which is a hardware device used for acquiring radiographic images. There is no mention of this being a software-only component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring radiographic images of the dento-maxillofacial region and replacing film/screen systems in panoramic dental diagnostic procedures. This involves imaging the patient directly, not analyzing samples taken from the patient.
- Nature of IVDs: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
- Imaging Modality: The input imaging modality is Radiographic, which is an in-vivo imaging technique (imaging within the living body).
Therefore, the CDR-PAN Panoramic Dental Digital Imager falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CDR-PAN Panoramic Dental Digital Imager is indicated for use in acquiring radiographic images at the dento-maxillofacial region. It is intended to replace radiographic film/screen systems in panoramic dental diagnostic procedures.
Product codes
MUH, MQB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Radiographic images
Anatomical Site
dento-maxillofacial region
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines representing the body and a head-like shape at the top.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Enrico Renzi Director of Quality Control and Compliance Schick Technologies, Inc. 30-30 47th Avenue LONG ISLAND CITY NY 11101
AUG 23 2013
Re: K982661
Trade/Device Name: CDR-Pan Model 4700 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH and MQB Dated: October 28, 1998 Received: October 30, 1998
Dear Mr. Renzi:
This letter corrects our substantially equivalent letter of December 11, 1998.
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
1
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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Page 1 of 1
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K982661 |
| Device Name: | (DR-PAN Model 4700 |
Indications For Use:
7.2. Indications For Use
The CDR-PAN Panoramic Dental Digital Imager is indicated for use in acquiring radiographic images at the dento-maxillofacial region. It is intended to replace radiographic film/screen systems in panoramic dental diagnostic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off)Division of Reproductive, Abdominal, ENT,and Radiological Devices510(k) NumberK982661 | (Division Sign-Off) | Division of Reproductive, Abdominal, ENT, | and Radiological Devices | 510(k) Number | K982661 | |
|---|---|---|---|---|---|---|
| (Division Sign-Off) | ||||||
| Division of Reproductive, Abdominal, ENT, | ||||||
| and Radiological Devices | ||||||
| 510(k) Number | K982661 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
Pres (Per 21 CFR 801.109)
ver-Tue-Counter Use__
(Optional Format 1-2-96)