(85 days)
Not Found
No
The summary describes a standard digital x-ray sensor and image processing unit without mentioning AI or ML capabilities.
No
The device is described as an intra-oral imaging system intended for diagnostic use, specifically to collect and convert dental x-ray photons into electronic impulses for diagnostic viewing. It replaces film/screen systems in general dental diagnostic procedures. There is no mention of it treating or preventing any disease or condition.
Yes
The "Intended Use / Indications for Use" states that the electronic impulses "may be stored, viewed, and manipulated for diagnostic use by dentists," and the "Device Description" also mentions its use in "general dental diagnostic procedures."
No
The device description explicitly states "EzSensor T is a solid state x-ray imager designed for dental radiographic applications" and "The captured digital image is transferred to Personal Computer via USB interface port," indicating it includes hardware components (the imager and USB interface).
Based on the provided information, the EzSensor T, Intra-oral Imaging System, is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The EzSensor T is an imaging system that captures dental x-ray images directly from the patient's mouth (intra-oral). It does not analyze biological specimens.
- The intended use is to collect dental x-ray photons and convert them into electronic impulses for diagnostic use by dentists. This is a direct imaging process, not an in vitro test.
Therefore, the EzSensor T falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
EzSensor T, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Product codes
MQB, EAP, MOB
Device Description
EzSensor T is a solid state x-ray imager designed for dental radiographic applications. EzSensor T provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.
Mentions image processing
Medical Image Processing Unit
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), IEC 60601-1-1(2ª edition, 2000) for use with IEC60601-1(Al+A2, 1995) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.
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
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically 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 inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
K113360
Page 1 of 4
Special 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date
November 10, 2011
Manufacturer
HUMANRAY Co., Ltd.
1,3F 23-8, Seokwoo-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea Republic
Tel: +82-31-8015-6264
Fax: +82-31-8015-6394
Contact person: Mr. Sang-Wook, Yang
United States Sales Representative (U.S. Designated agent)
Dave Kim / Mtech Group
· 12946 Kimberley Ln, Houston, TX 77079
Tel: +713-467-2607
Fax: +713-464-8880
Contact person: Mr. Dave Kim
Trade/Proprietary Name: EzSensor T
Common Name:
Medical Image Processing Unit
Classification Name:
Solid State X-Ray Imager (21CFR 892.1650, Product Code MQB) Description:
EzSensor T is a solid state x-ray imager designed for dental radiographic applications. EzSensor T provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental
1
diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.
Indication for use:
in
EzSensor T, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Predicate Device:
| Manufacturer | : HUMANRAY Co., Ltd. |
|---|---|
| Device | : EzSensor |
| 510(k) Number | : K090526 (Decision Date - DEC/02/2009) |
Substantial Equivalence:
EzSensor T described in this 510(k) has the same intended use and similar technical characteristics as EzSensor (K090526) of HUMANRAY Co., Ltd.
| Characteristic | Proposed
HUMANRAY Co., Ltd.
EzSensor T | Predicate
HUMANRAY Co., Ltd.
EzSensor |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Image: Proposed HUMANRAY Co., Ltd. EzSensor T | Image: Predicate HUMANRAY Co., Ltd. EzSensor |
| 510(k) number | - | K090526 |
| Indications
for use | EzSensor T, Intra-oral Imaging System,
is intended to collect dental x-ray
photons and convert them into electronic
impulses that may be stored, viewed,
and manipulated for diagnostic use by
dentists. | EzSensor, Intra-oral Imaging System,
is intended to collect dental x-ray
photons and convert them
into
electronic impulses that may be
stored, viewed, and manipulated for
diagnostic use by dentists. |
2
K113360
Page 3 of 4
| Device Description | EzSensor T is a solid state x-ray imager
designed for dental radiographic
applications. EzSensor T provides digital
image capture for conventional film/screen
radiographic dental examinations. The
device is used to replace radiographic
film/screen systems in general dental
diagnostic procedures. The captured digital
image is transferred to Personal Computer
via USB interface port. | EzSensor is a solid state x-ray imager
designed for dental radiographic
applications. EzSensor provides digital
image capture for conventional
film/screen radiographic dental
examinations. The device is used to
replace radiographic film/screen systems
in general dental diagnostic procedures.
The captured digital image is transferred
to Personal Computer via USB interface
port. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensor
Dimension(mm) | Size "1.0" : 36.8x26.1
Size "1.5" : 38.7x29.2
Size "2.0" : 42.8x31.5 | Size "1.0" : 35.7x25.2
Size "1.5" : 38.7x29.2 |
| Sensor
Thickness | 4.95 | 4.9 |
| Active Area(mm) | Size "1.0" : 20.02x30.03
Size "1.5" : 24.01x33.04
Size "2.0" : 26.04x36.05 | Size "1.0" : 20.02x30.03
Size "1.5" : 24.08x31.85 |
| USB Module | Integrated USB 2.0 module | Integrated USB 2.0 module |
| Pixel Size(\u03bcm) | 35x35 | 35x35 |
| Pixel Matrix | Size "1.0" : 572x858 pixel
Size "1.5" : 686x944 pixel
Size "2.0" : 744x1030 pixel | Size "1.0" : 572x858 pixel
Size "1.5" : 686x944 pixel |
| Pixel
Pitch(Spacing) | 0.035 mm x 0.035 mm | 0.035 mm x 0.035 mm |
| Resolution | 14.28 lp/mm (Intrinsic Property) | 14.3 lp/mm (Intrinsic Property) |
The indications for use, material, form factor, performance, and safety characteristics between EzSensor T and the predicate device are the same. The primary differences are size, active area and scintillator layer materials; GOS (Gd2O2S: Tb) for EzSensor T and cesium iodide (CsI) for EzSensor, respectively. Accordingly we can claim the substantially equivalence of EzSensor T.to the predicate device.
Safety, EMC and Performance Data:
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), IEC 60601-1-1(2ª edition, 2000) for use with IEC60601-
3
1(Al+A2, 1995) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.
Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. HUMANRAY Co., Ltd. concludes that EzSensor T is safe and effective and substantially equivalent to predicate device as described herein. ﻜ
END
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
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
Humanray Co., Ltd. Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberly Lane HOUSTON TX 77079
AUG 2 3 2013
Re: K113360
Trade/Device Name: EzSensor T Regulation Number: 21 CFR 872.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP and MOB Dated: January 11, 2012 Received: January 12, 2012
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of February 7, 2012.
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
5
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
6
Indications for Use Statement
510(K) Number (if known):
Device Name: EzSensor T
Classification: Solid State X-Ray Imager
Indications for Use:
EzSensor T, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Prescription Use______________________________________________________________________________________________________________________________________________________________ V Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
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