(43 days)
No
The description focuses on the hardware (sensor, WiFi transmission) and basic image processing features (zoom, contrast, inversion, pseudo color). There is no mention of AI, ML, or any advanced analytical capabilities beyond standard image manipulation.
No
The device is described as being used for "diagnosis purpose" and captures "digital images of human oral tissue and teeth" for dental practitioners. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is used for diagnosis purpose, by dental practitioners."
No
The device description explicitly states "Krystal-X WiFi is a wireless digital X-ray sensor for intraoral radiography," indicating it includes a hardware component (the sensor) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: 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. These tests are performed outside the body (in vitro).
- Device Function: The KRYSTAL-X WiFi system is an imaging device that captures X-ray images of the human oral tissue and teeth directly from the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for providing instant digital images for diagnosis by dental practitioners, which is a form of medical imaging, not in vitro testing.
Therefore, the KRYSTAL-X WiFi digital system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The wireless digital X-ray sensor is intended to capture an intraoral digital X-ray for diagnostic purposes. The process is automatic; it continues by transmitting the digital image to a Personal Computer via WiFi. It requires additional components such as conventional X-ray tube and image capture software, currently available commercially.
Product codes
MUH, MQB
Device Description
Krystal-X WiFi is a wireless digital X-ray sensor for intraoral radiography.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human oral tissue and teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioners, exclusively in a healthcare specific environment.
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)
K061114, K050693, K022953, K053172
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
APR 5 - 2007
510(k) Summary
This summary of Safety and Effectiveness is in accordance with the requirements of:
-
Device Description .
Krystal-X WiFi 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 for diagnostic purposes. The process is automatic; it continues by transmitting the digital image to a Personal Computer via WiFi. It requires additional components such as conventional X-ray tube and image capture software, currently available commercially. -
Summary of Substantial Equivalence Comparison .
K061114 - WDS X-RAY, CEFLA
K050693 - ACCENT, AIR TECHNIQUES, INC.
K022953 - CDR Wireless, SCHICK TECHNOLOGIES
K053172 - KRYSTAL-X,
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 a method of wireless transmission to transmit the digital image to a personal computer for viewing and further management of the file. The proposed and the predicated devices are substantially equivalent;
- WDS X-RAY is a wireless digital X-Ray sensor that captures an intraoral . X-Ray, when exposed to X-Rays and transmits images via Bluetooth wireless technology, for diagnostic purposes ..
- . ACCENT is a wireless sensor very similar to WDS, which also transmits images via Bluetooth wireless technology.
- . KRYSTAL-X is a conventional system, non-wireless, but identical in all other regards to KRYSTAL-X WiFi.
1
- CDR Wireless is a wireless sensor that captures and transmits images via . RF (Radio Frequency).
KRYSTAL-X WiFi is most similar in components to the original KRYSTAL-X, from our company, which was cleared by your agency on June 9, 2006.
The only difference is the method of communication between the sensor and the computer from a wired to a wireless interface. This modification is similar to the one Schick Technologies did when they introduced the CDR Wireless which modified their original CDR.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
APR 5 = 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OWANDY, Inc. % Mr. Claude Berthoin President/Owner Video Dental Concepts, Inc. 110 East Granada Boulevard. Suite 207 ORMOND BEACH FL 32176
Re: K070505
Trade/Device Name: Krystal-X WiFi Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH and MQB Dated: March 29, 2007 Received: April 2, 2007
Dear Mr. Berthion:
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 indivet 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 in microad in microade of the 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 masil 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/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. The word "Centennial" is written in a cursive font below the acronym. There are three stars at the bottom of the logo.
Protecting and Promoting Public Lands
3
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/cdrl/industry/support/index.html.
Sincerely yours,
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
4
INDICATION FOR USE
Applicant: Owandy
510(k) Number (if known): K053172 (Krystal-X Standard)
Device Name: Krystal-X WiFi
Indication for use: The KRYSTAL-X WiFi digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube (which is a third party device, not part of Krystal-X WiFi), and placing an electronic sensor in the patients' mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures instantaneously and transmits the images by WiFi to the computer. The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are: high definition, ensuring high-value diagnostics, and reduction of X-rav dosage. In no case, is it to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The WiFi device modification to our model Krystal-X in no way alters the indications for use of this device beyond what was originally approved in K053172.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Syzmon
Division of Renmountive, Abdomin
escription Use ✓