COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D

• K Number: K090171
• Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
• Manufacturer: E-WOO TECHNOLOGY
• Date Cleared: 2009-04-30 ( 97 days)
• Product Code: OAS
• Regulation Number: 892.1750

Intended Use

The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

Device Description

The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

Predicate Devices

K082350, K070658

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard computed tomography x-ray system for dental imaging and diagnosis, focusing on image reconstruction from x-ray data. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The description of the technology is consistent with traditional image processing techniques used in CT.

Therapeutic

No
The device is described as a "diagnostic x-ray system" intended for "dental examination and diagnosis of diseases," not for treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "diagnostic x-ray system" intended for "diagnosis of diseases".

SaMD (Software as a Medical Device)

No

The device is described as a "computed tomography x-ray system," which inherently includes hardware components for generating and detecting x-rays, in addition to any software for image reconstruction and processing. The performance studies also mention electrical, mechanical, and environmental safety testing, which are relevant to hardware.

IVD (In Vitro Diagnostic)

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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
• Device function: The PaX-REVE3D is an X-ray system that produces images of the teeth, jaw, and oral structure. It works by using X-rays to create images of the internal anatomy, not by analyzing biological samples.
• Intended Use: The intended use clearly states it's for "dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data". This involves imaging the body directly, not testing samples from the body.

Therefore, the PaX-REVE3D falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

Product codes (comma separated list FDA assigned to the subject device)

OAS

Device Description

The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

Product features

(1). Condition of Input
1-1. Rated input voltage : AC 110 / 220V +/- 10%, Single-Phase

• 1-2. Guaranteed working voltage

1. 110V Mode : 100~120V

• 2. 220V Mode : 200 ~240V
• 1-3. Possible working voltage
• 1. 110V Mode : 90 ~130V
• 2. 220V Mode : 180 ~ 250V
• 1-4. Total Power : 2.0KVA
  Output Power Max.: 90kV、10mA, 30s
  Nominal electric power: 40-90kV, 2-10mA, 8-30s
  1-5. Rated input frequency : 50Hz / 60Hz
  1-6. Insulation withstanding : below than 1.5KV cap for more than one minute
  between first test and second test.
  1-7. Circuit Breaker: 13.5A

(2) Capture mode

• 1-1. Capture modes of Panoramic System
• Panoramic for adults
• Panoramic for children
• Left side of dentition
• Right side of dentition
• Anterior part of dentition
• TMJ (Mouth open and close) TBD
  Anterior view of asal(maxillary) sinuses - TBD
• 1-2. Capture modes of Cephalometric System
• Lateral view
  Posterior-Anterior view
  Carpus view
• 1-3. Capture mode of Computed Tomography System 3D image

(3) X-ray Generator
1-1. Ripple : 50°C

• 1-6. Tube current : 1 10 mA (adjustable by 1mA)
  For Panoramic Unit (2 - 10mA)
  For Cephalometric Unit (2 - 10mA)
  For CT Unit ( 2 - 10mA)
• 1-7. Guaranteed working voltage
• 1. 110V Mode : 100~120V
• 2. 220V Mode : 200 ~240V
• 1-8. Possible working voltage
• 1. 110V Mode : 90 ~130V
• 2. 220V Mode : 180 ~ 250V
     1-9. Cooling : by force, one minute for cooling / protect ≥50°C

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

teeth, jaw and oral structure

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physicians, dentists, and x-ray technologists

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, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, EN/IEC 60601-2-32 and EN/IEC 60601-1-44 was performed, and EMC testing was conducted in accordance with a standard EN/IEC 60601-1-2. All test results were satisfactory.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K082350, K070658

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

KC9CI7I/

510(k) Summary

APR 3 0 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 892.1750.

Date: Dec. 01, 2008

• 1. Company and Correspondent making the submission:
     E-WOO Technology Co., Ltd. Name:

Address: 1F, 4F, Yunmin Technotown, 473-4, Bora-Dong, Giheung-Gu, Yongin-Si,

Gyeonggi-Do, 446-904, KOREA

Telephone: [phone]

Fax : [phone]

Mr. DongTaek, Oh Contact :

Internet : http://www.e-wootech.com

• 2. Device :

Trade/proprietary name	: PaX-Reve3D
Common Name	: Computed Tomography X-Ray System
Classification Name	: X-ray, tomography, computed, dental

• 3. Predicate Devices

Predicate Device A:
Manufacturer	: Vatech Co., Ltd.
Device	: PAX-500
510(k) Number	: K082350
Predicate Device B:
Manufacturer	: E-WOO Technology Co., Ltd.
Device	: EPX-Impla; Picasso-Trio
510(k) Number	: K070658

4 . Classifications Names & Citations :

21CFR 892.1750, OAS, X-ray, tomography, computed, dental, Class2

1

5. Description :

• 5.1 General
  The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

5.2 Product features

(1). Condition of Input

1-1. Rated input voltage : AC 110 / 220V ± 10%, Single-Phase

• 1-2. Guaranteed working voltage

1. 110V Mode : 100~120V

• 2. 220V Mode : 200 ~240V
  • 1-3. Possible working voltage
    • 1. 110V Mode : 90 ~130V
    • 2. 220V Mode : 180 ~ 250V
  • 1-4. Total Power : 2.0KVA

Output Power Max.: 90kV、10mA, 30s

Nominal electric power: 40-90kV, 2-10mA, 8-30s

1-5. Rated input frequency : 50Hz / 60Hz

1-6. Insulation withstanding : below than 1.5KV cap for more than one minute

between first test and second test.

1-7. Circuit Breaker: 13.5A

(2) Capture mode

• 1-1. Capture modes of Panoramic System
  • Panoramic for adults
  • Panoramic for children
  • Left side of dentition
  • Right side of dentition
  • Anterior part of dentition
  • TMJ (Mouth open and close) TBD

E-WOO Technology Co., Ltd.

2

Anterior view of asal(maxillary) sinuses - TBD

• 1-2. Capture modes of Cephalometric System
  • Lateral view

Posterior-Anterior view

Carpus view

• 1-3. Capture mode of Computed Tomography System 3D image
  (3) X-ray Generator

1-1. Ripple : 50°C

• 1-6. Tube current : 1 10 mA (adjustable by 1mA)
  For Panoramic Unit (2 - 10mA)

For Cephalometric Unit (2 - 10mA)

For CT Unit ( 2 - 10mA)

• 1-7. Guaranteed working voltage
  • 1. 110V Mode : 100~120V
  • 2. 220V Mode : 200 ~240V
• 1-8. Possible working voltage
  • 1. 110V Mode : 90 ~130V
  • 2. 220V Mode : 180 ~ 250V

1-9. Cooling : by force, one minute for cooling / protect ≥50℃

6. Indication for use :

The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray

E-WOO Technology Co., Ltd.

3

KC9CI7/

510(k) Submission - PaX-Reve3D

system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

• 7. Comparison with predicate device :
     The subject device and predicate devices are substantially equivalent, having the same intended use, form factor, material, performance and safety characteristics. The differences are cosmetic, arrangement and components use only. The predicate device's 510K marketing clearance letters, 510K summaries and product information are found in TAB O, P Q, respectively.
• 8. Safety, EMC and Performance Data :
     Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, EN/IEC 60601-2-32 and EN/IEC 60601-1-44 was performed, and EMC testing was conducted in accordance with a standard EN/IEC 60601-1-2. All test results were satisfactory.

9. Conclusions:

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 PaX-Reve3D is safe and effective and substantially equivalent to predicate devices as described herein.

• 10. 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with three lines representing its wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 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: K090171 ·

Trade/Device Name: PaX-Reve3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: March 24, 2009 Received: March 30, 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.

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.

5

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)

[phone] [phone] [phone] [phone]

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 [phone] or [phone] 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

6

Indications for Use

510(k) Number (if known):

K090171

Device Name: PaX-Reve3D

Classification: X-Ray, Tomography, Computed, Dental

Indications for Use:

The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. TThe device is operated and used by physicians, dentists, and x-ray technologists.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (Part 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 Of The

(Division Sigh-Off) Division of Reproductive, Abdominal Radiological Devic 510(k) Number

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