(46 days)
Not Found
No
The summary describes a standard digital X-ray sensor and does not mention any AI/ML components or image processing capabilities beyond basic image capture and transmission.
No
The device is described as an X-ray sensor for capturing intraoral digital images for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device captures images for "diagnostic purposes."
No
The device description explicitly states it is a "wireless digital X-ray sensor," which is a hardware component designed to capture images. The summary also mentions transmitting the image via Bluetooth, implying a physical sensor is involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "wireless digital X-ray sensor for intraoral radiography" and its intended use is to "capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes."
- Modality: The input imaging modality is X-Rays, which is an in vivo imaging technique (performed on a living organism), not an in vitro technique (performed outside the body).
- Sample Type: The device captures images directly from the patient's mouth (intraoral), not from a sample taken from the patient.
Therefore, this device falls under the category of a medical imaging device, specifically for dental radiography, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The wireless digital X-ray sensor is intended to capture an intraoral digital X-ray image when exposed to X-Rays for diagnostic purposes. The process is automatic; it continues by transmitting the digital image to a Personal Computer via a wireless Bluetooth connection. It requires additional components such as conventional X-ray tube and image capture software, currently available commercially.
Product codes
MUH
Device Description
WDS is a wireless digital X-ray sensor for intraoral radiography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Rays
Anatomical Site
intraoral
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)
Not Found
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 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
KO61114
510(K) SUMMARY
JUN - 6 2006
This summary of Safety and Effectiveness is in accordance with the requirements of:
- Device Description: .
WDS is a wireless digital X-ray sensor for intraoral radiography.
Intended Use: .
The wireless digital X-ray sensor is intended to capture an intraoral digital X-ray image when exposed to X-Rays for diagnostic purposes. The process is automatic; it continues by transmitting the digital image to a Personal Computer via a wireless Bluetooth connection. It requires additional components such as conventional X-ray tube and image capture software, currently available commercially
- . Summary of Substantial Equivalence Comparison:
K031448, RSV, VISIODENT
K050693 ACCENT, AIR TECHNIQUES, INC
K990002 QUICKRAY DSX730, JULIE ALLIANCE
The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the The proposed and the predicated devices are substantially equivalent; file.
-
ACCENT is a wireless sensor very similar to WDS, the existing minor differences regarding use ergonomics only.
-
QuickRay DSX730 is connected to the personal computer through a USB connector, and powered off the same connection.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 6 2006
CEFLA s.c.r.l. c/o Mr. Claude D. Berthoin President Video Dental Concepts, Inc. 110 E. Granada Blvd., Suite 207 ORMOND BEACH FL 32176
Re: K061114
Trade/Device Name: WDS Regulation Number: 21 CFR §872.1800 Regulation Name: Extraoral source x-ray system Regulatorv Class: II Product Code: MUH Dated: April 20, 2006 Received: April 21, 2006
Dear Mr. Berthoin:
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 (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.
Image /page/1/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top and the letters "FDA" in a large, bold font in the center. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial". The text "Centennial" is surrounded by a circular border with additional text.
Protecting and Promoting Public Health
2
Page 2 -
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) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATION FOR USE
Applicant: CEFLA s.c.r.l.
510(k) Number (if known): K061114
Device Name: WDS
Indication For Use: the wireless digital RX sensor is intended to capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes.
The process is automatic and continues transmitting to a Personal Computer the digital image by wireless Bluetooth connection.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
preserí
Daniel R. Leggett
(Division Sign-Off)
Division of Reproductiv and Radiological Devic 510(k) Number