(94 days)
No
The summary describes a digital X-ray sensor and its hardware/software connectivity, with no mention of AI or ML for image processing or analysis.
No
The device is used to acquire diagnostic images, not to treat a disease or condition.
No
The device is an imaging acquisition device. While the images it produces may be used for diagnosis, the device itself does not perform any diagnostic function.
No
The device description explicitly details hardware components like a USB-driven digital sensor, scintillating material, CMOS technology, and a dedicated electronic assembly, indicating it is a hardware device with associated software.
Based on the provided information, the DEXIS sensor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DEXIS Sensor Function: The DEXIS sensor acquires intra-oral radiography images using X-rays. It directly images the anatomical structure (teeth and surrounding tissues) within the mouth. It does not analyze biological specimens.
Therefore, the DEXIS sensor falls under the category of a medical imaging device, specifically for dental radiography.
N/A
Intended Use / Indications for Use
The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
Product codes
MUH
Device Description
The DEXIS sensor is an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology.
The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra-oral applications.
The DEXIS sensor supports USB 2.0 and USB 1.1 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays
Anatomical Site
dental intra-oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
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
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.
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Image /page/0/Picture/1 description: The image shows the logo for "sybron dental specialties". The text is in a bold, sans-serif font. A curved line is above the text, creating a visual element that frames the brand name.
Section III - 510(k) Summary of Safety and Effectiveness
MAY 2.8 2009
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz - Contact Person
Date Summary Prepared: February 2009
Device Name:
- Trade Name DEXIS Sensor .
- Common Name Digital X-ray ●
- Classification Name Extraoral source x-ray system, per 21 CFR § 872.1800 .
Devices for Which Substantial Equivalence is Claimed:
- Schick Technologies, CDR (K072134) ●
- Suni Medical Imaging, Inc., SuniRay II Digital Radiographic System (K070219) .
Device Description:
The DEXIS sensor is an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology.
The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra-oral applications.
The DEXIS sensor supports USB 2.0 and USB 1.1 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.
Intended Use of the Device:
The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
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Image /page/1/Picture/0 description: The image shows the logo for "sybron dental specialties". The text is in a bold, sans-serif font and is black. A curved line is above the text, starting from the left and ending above the "s" in "specialties".
Substantial Equivalence:
| Descriptive
Information | DEXIS Sensor | CDR (K072134) | SuniRay II Digital
Radiographic System
(K070219) |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The DEXIS sensor is a
USB-driven digital sensor
which is intended to
acquire dental intra-oral
radiography images. The
DEXIS sensor shall be
operated by healthcare
professionals, who are
educated and competent to
perform the acquisition of
dental intra-oral
radiographs. The DEXIS
sensor can be used either in
combination with special
positioning devices to
facilitate positioning and
alignment with the x-ray
beam or it may also be
positioned by hand with the
assistance of the patient. | The computed oral radiology
system is intended for intra-
oral x-ray examinations and
indicated for dental patients. It
produces instant, digital, intra-
oral x-ray images of a
patient's mouth while
reducing the necessary x-ray
dosage. | The SuniRay II Digital
Radiography System is used
to collect dental x-ray
photons and convert them
into electronic impulses that
may be stored, viewed, and
manipulated for diagnostic
use by dentists. |
| Number of
Sensors | 1 | 3 | 2 |
| Sensor Size
(mm) | 30 x 39 | 31 x 22
37 x 24
43 x 30 | 39.5 x 26
43.5 x 31.5 |
| Technology | CMOS | Same | Same |
| Interface to
PC | USB | Same | Same |
| Dynamic
Range | 16,384:1 | 4096:1 | 4096:1 |
| Sensor Cable
Length (m) | 2.8 | 2 | 1 |
Conclusion: The DEXIS Sensor is substantially equivalent to other legally marketed devices in the The DEXIS Sensor is substantially equivalent in intended use and technical United States. characteristics to the CDR marketed by Schick Technologies, Inc. and SuniRay II Digital Radiographic System marketed by Suni Medical Imaging, Inc.
. ***
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Image /page/2/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird with its wings spread, facing to the right. The bird's body is represented by three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
MAY 28 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEXIS, LLC
% Ms. Claudia Ortiz
Compliance Director, Regulatory Affairs & Quality Assurance Sybron Dental Specialties, Inc. 1717 West Collins Drive
ORANGE CA 92656
Re: K090458
Trade/Device Name: DEXIS Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: May 8, 2009 Received: May 11, 2009
Dear Ms. Ortiz:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other
(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)
(240) 276-0115 (240) 276-0115 (240) 276-0120 (240) 276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K090458
Device Name: DEXIS Sensor
Indications for Use:
The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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 and
Radiological Devices
510(k) Number K090454
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