Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on digital image capture and transfer, with no mention of AI or ML for image analysis or interpretation.

Therapeutic

No
The device is used for diagnostic purposes, not for therapy.

Diagnostic

Yes
The text explicitly states that the device is used for "diagnostic use by dentists" and "for general dental diagnostic procedures".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "solid state x-ray imager" and a "digital image capture" device that replaces film/screen systems, indicating it is a hardware device that captures images. While it transfers data to a PC via USB and includes software validation, the core function is hardware-based image acquisition.

IVD (In Vitro Diagnostic)

Based on the provided information, the EzSensor is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
EzSensor Function: The EzSensor is an imaging device that captures dental x-rays of the human body (specifically intra-oral structures). It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states it's for collecting dental x-ray photons and converting them into electronic impulses for diagnostic use by dentists. This is an in vivo (within the living body) diagnostic process, not in vitro (in glass/outside the living body).

Therefore, the EzSensor falls under the category of medical imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EzSensor is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

Product codes

MQB, MUH

Device Description

The EzSensor is a solid state x-ray imager designed for dental radiographic applications. The 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.

The EzSensor configuration

PC
Image Interface Box (Read-out Box)
X-ray sensor

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

x-ray

Anatomical Site

intra-oral

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 EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072134

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

K090526

510(k) Summary

Prepared:	September 1, 2009
-----------	-------------------

- 2 2009

1. Submitter:

Company Name	: E-WOO Technology Co., Ltd.
Company Address	: 1F, 4F, Yunmin Technotown, 473-4, Bora-dong, Giheung-gu,
Yongin-si, Gyeonggi-do, 446-904, Korea
U.S. Agent Address	: 256 N. Sam Houston Pkwy E. #115
Houston, TX 77060
Contact person	: Vincent Lee
Phone Number	: (281)598-8139
Fax Number	: (281) 598-8150

1. Identification of the Device :

Reason for 510(k)	: New Model
Manufacturer	: E-WOO Technology Co., Ltd
Trade Name	: E-Woo Technology
Model Name	: EzSensor
Classification Name	: MQB, Solid State X-ray Imager
FDA 510(k) #	: K090526

1. Equivalent legally marketed device :

Manufacturer	: Schick Technologies, Inc.
Trade Name	: Schick
Model Name	: CDR
Classification Name	: MQB, Solid State X-Ray Imager
FDA 510(k) #	: K072134

1. Indications for Use (intended use):
  Indicated for 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.

1

1. Description of the device :
  The EzSensor is a solid state x-ray imager designed for dental radiographic applications. The 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.

The EzSensor configuration

イ PC
イ Image Interface Box (Read-out Box)
イ X-ray sensor

Image /page/1/Figure/7 description: The image shows a diagram of a sensor system connected to a computer. The system includes a sensor connected to an image interface box via a sensor cable. The image interface box is connected to a computer via a USB cable, and the computer is connected to a display.

ﻟﻤﺰﺓ ﻳ

2

510(k) Submission – EzSensor

| | Predicate:
CDR (K072134) | Proposed:
EzSensor (K090526) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Image: CDR (K072134) | Image: EzSensor (K090526) |
| Common/
Classification
Name | Solid State X-Ray Imager | Solid State X-Ray Imager |
| Intended Use | 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. | 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. |
| Device Description | - | The EzSensor is a solid state x-ray
imager designed for dental
radiographic applications. The
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 Dimensions (mm) | Size "0": 31x22
Size "1": 37x24
Size "2": 43x30 | Size "1.0": 35.7x25.2
Size "1.5": 38.7x29.2 |
| Sensor Thickness (mm) | 5 | 4.9 |
| Active Area (mm) | Size "0": 24x18
Size "1": 30x20
Size "2": 36x25.6 | 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 (um) | 0.40x0.40 | 0.35x0.35 |

ులు

1. Safety and Effectiveness, comparison to predicate device

3

1. Safety, EMC and Performance Data :
  In all material respects the "EzSensor" is substantially equivalent to CDR of Schick Technologies, Inc. (K072134) - Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
Testing information and Conclusion 8.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification E-WOO Technology Co., Ltd. concludes that The EzSensor is safe and effective and substantially equivalent to predicate devices as described herein.
1. E-WOO Technology Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

4

Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", arranged in a circular fashion.

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

DEC - 2 2009

E-Woo Technology Co., Ltd. % Mr. Vincent Lee Regulatory Compliance Officer E-Woo Technology USA, Inc. 256 North Sam Houston Pkwy E. #115 HOUSTON TX 77060

Re: K090526

Trade/Device Name: EzSensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 8, 2009 Received: October 13, 2009

Dear Mr. Lee:

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 (PMA), it your be subject to 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.

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

5

Page 2 -

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fdaggov/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lucia M. Merritt

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

Indications for Use

K CG 05 26 510(k) Number(if known):

Device Name: EzSensor

Indications for Use:

The EzSensor is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation(ODE)

Page 1 of _ 1

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

]