ANYRAY PORTABLE X-RAY SYSTEM by E-WOO TECHNOLOGY CO., LTD.

"AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Device Description

"AnyRay" is a wireless Portable X-Ray System that operates on DC22.5V supplied by a rechargeable Lithum-Polymer battery pack. The X-ray tubehead, X-ray controls and power source are ssembled into a single hand-held enclosure. The Package includes DC adaptor and Chair (Option) This equipment generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of xray generator, controller, beam limiting device and chair (Option). Operating principle is that x-ay generated by high voltage electricity into x-ray tube, which (Openatifs primelpes in this x-ray images on receptor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the "AnyRay" Portable X-Ray System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not specify explicit "acceptance criteria" in terms of performance metrics like accuracy, sensitivity, or specificity for the device itself in producing diagnostic images. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (NOMAD Dental X-Ray System, K051795) based on technical and safety specifications.

The table below summarizes the key features and performance parameters compared to the predicate device, which implicitly serve as the "acceptance criteria" for demonstrating equivalence in a 510(k) submission of this nature. The "Reported Device Performance" column directly reflects the information provided for the "AnyRay" device.

Feature	Acceptance Criteria (Predicate Device K051795)	Reported Device Performance ("AnyRay")
Intended Use	As extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians. (Both adult and pediatric subjects)	As extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians. (Both adult and pediatric subjects)
Body Size (L x H x W)	13"L x 11.5"H x 5.5"W	8.6"L x 6.0"H x 5.8"W
Weight	8.5 lbs	5.3 lbs
Source to Skin Distance	20cm	20cm
Cone Diameter	6cm	6.5cm
User Interface	Up-down buttons for exposure time selection, with timer display	Up-down buttons for exposure time selection, with timer display
Backscatter Radiation Protect	6.75" dia. Pb-filled acrylic plastic scatter shield	Circular scatter shield
Exposure Switch	On tubehead assembly/control panel	On tubehead assembly/control panel
Tubehead Mounting	Handheld	Handheld
Energy Source	Rechargeable 14.4V DC NiCd battery pack	Rechargeable 22.5V DC Lithum-Polymer battery pack.
Exposure Time	0.01 – 0.99 seconds in 0.01 increments	0.06 s ~ 2.0 s seconds in 0.01 increments
Time Accuracy	± (10% + 1ms)	± (10% + 1ms)
mA	2.3mA Fixed	2 mA (Fixed)
kVp	60kVp Fixed	60 kVp (Fixed)
Waveform	Constant Potential (DC)	Constant Potential (DC)
Duty Cycle	1:60	1:60
Electrical Safety Standards	IEC60601-1, UL60601-1, EN60601-1	IEC60601-1, EN60601-1
EMI Standards	IEC 60601-1-2	IEC 60601-1-2
Performance Standards	21 CFR 1020.30, 1020.31, IEC60601-1-3, IEC60601-2-7	IEC60601-1-3, IEC60601-2-7, IEC60601-2-28, IEC60601-2-32
Biocompatibility	- (Not explicitly stated or applicable for predicate)	Not applicable (No direct, indirect contact with patient)

Study Proving Device Meets Acceptance Criteria:

The provided document describes a 510(k) premarket notification, which is a submission to the FDA to demonstrate substantial equivalence to an existing legally marketed device (the predicate device). It is not a clinical study in the traditional sense designed to prove superior performance or a specific diagnostic accuracy.

The "study" here is essentially the comparative analysis of the technical specifications and safety standards between the "AnyRay" device and its predicate, the NOMAD Dental X-Ray System (K051795). The conclusion states: "E-Woo Technology Co.,Ltd. concludes that the Portable X-Ray System "AnyRay" 's safety and effectiveness are substantially equivalent to predicate devices..." This conclusion is drawn from the detailed technical comparison presented in the table.

Here's an analysis of the requested information based on the 510(k) submission content:

2. Sample Size Used for the Test Set and the Data Provenance:

Test Set: There is no "test set" in the context of image data for diagnostic performance evaluation mentioned in this document. The evaluation is based on a comparison of device specifications and adherence to recognized standards.
Data Provenance: The data provenance is the device specifications provided by the manufacturer, E-Woo Technology Co., Ltd. for the "AnyRay" and specifications of the predicate device (NOMAD).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable to this type of 510(k) submission. There was no diagnostic image-based "ground truth" to be established for a test set by external experts.

4. Adjudication Method for the Test Set:

This information is not applicable. There was no test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This document pertains to an X-ray device (hardware) and its substantial equivalence in terms of technical specifications and safety, not an AI or software algorithm that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This document is for a physical X-ray device, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable in the context of diagnostic performance. The "ground truth" here is effectively the accepted technical specifications and safety compliance demonstrated by the predicate device and relevant industry standards (e.g., IEC, FDA regulations).

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no "training set" for which ground truth would be established.

Summary

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K081899

AUG 2 1 2008

EXHIBIT 2 510(k) Summary

E-Woo Technology Co., Ltd. 1F/4F/5F, Yunmin Technotown, 473-4, Bora-Dong, Giheung-Gu, Yongin-Si, Gyeonggi-Do, Korea 446-904 Tel: 82-31-899-7967 Fax: 82-31-286-3007 Taewoo Kim, President & CEO January 15, 2008

Identification of the Device: Proprietary-Trade Name: Portable X-Ray System "AnyRay" Classification Name : Unit, X-Ray, Extraoral with Timer / Product Code EHD Common/Usual Name: Portable X-Ray System
Equivalent legally marketed device: This product is similar in design and identical in function to Portable Dental X-Ray System Model "NOMAD" (K051795, Aribex, Inc)
Indications for Use (intended use):

"AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-fay source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Description of the device:

Feature	Predicate:(NOMAD TM Dental X-Ray System, K051795)	New DevicePortable X-Ray System “AnyRay”
Manufacturer	Aribex, Inc.	E-Woo Technology Co., Ltd.
Intended Use	Both systems are intended as extraoral x-ray sources to be used with intraoral image receptorsfor diagnostic imaging by dentists or dental technicians.
Body Size andWeight	13"L x 11.5H x 5.5"W/ 8.5lbs	8.6"L x 6.0"H x 5.8"W/ 5.3lbs
Chair(Option)and Weight	-	18.8"L x 66.6"H x 27.0"W/76.1lbs
Source to skindistance	20cm	20cm

Cone diameter	6cm	6.5cm
User Interface	Up-down buttons for exposure timeselection, with timer display	Up-down buttons for exposure timeselection, with timer display
Backscatterradiationprotection	6.75" dia. Pb-filled acrylic plastic scattershield	Circular scatter shield
Exposureswitch	On tubehead assembly/control panel	On tubehead assembly/control panel
Tubeheadmounting	Handheld	Handheld
Energy Source	Rechargeable 14.4V DC NiCd battery pack	Rechargeable 22.5V DC Lithum-Polymerbattery pack.
Exposure Time	0.01 – 0.99 seconds in 0.01 increments	0.06 s ~ 2.0 s seconds in 0.01 increments
Time Accuracy	± (10% + 1ms)	± (10% + 1ms)
mA	2.3mA Fixed	2 mA(Fixed)
kVp	60kVp Fixed	60 kVp(Fixed)
Waveform	Constant Potential(DC)	Constant Potential(DC)
Duty Cycle	1:60	1:60
ElectricalSafetyStandards	IEC60601-1, UL60601-1, EN60601-1	IEC60601-1, EN60601-1
EMI Standards	IEC 60601-1-2	IEC 60601-1-2
PerformanceStandard	21 CFR 1020.30, 1020.31IEC60601-1-3IEC60601-2-7	IEC60601-1-3, IEC60601-2-7IEC60601-2-28, IEC60601-2-32
Biocompatibility	-	Not applicable (No direct, indirect contactwith patient)

1. Safety and Effectiveness, comparison to predicate device

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6. 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 E-Woo Technology Co.,Ltd. concludes that the Portable X-Ray System "AnyRay" 's safety and effectiveness are substantially equivalent to predicate devices (NOMAD™ Dental X-Ray System (K051795, Aribex, Inc)) as described herein.

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Image /page/2/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" written around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe. The figure is composed of three curved lines, and the globe is represented by a series of wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2008

E-Woo Technology Company, Ltd. % Mr. Tamas Borsai Responsible Third Party Official TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K081899

Trade/Device Name: "AnyRay" Portable X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: August 7, 2008 Received: August 11, 2008

Dear Mr. Borsai:

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 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.

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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 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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) :

Device Name : Portable X-Ray System "AnyRay"

Indications For Use : "AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Prescription Use _ v (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)

Page 1 of 1

Agnih Whang
(Division Sign-Off)

nivision of Reproductive, Abdominal and Radiological Devices 510(k) Number

7/39

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.