LogoFDA 510(k) Search
K Number
K082350
Device Name
PAX-500
Manufacturer
VATECH CO., LTD.
Date Cleared
2008-10-10

(56 days)

Product Code
OAS
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PaX-500 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 structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Device Description
PaX-500 is an extraoral dental digital x-ray source generating diagnostic X-ray imaging from Digital Tomography, Panoramic, and Cephalometric dental X-ray modality. This Xray system device is based on digital X-ray imaging sensor to capture X-ray digital tomogram scanned Image 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.
More Information

K063773

Not Found

No
The summary describes a standard digital x-ray system with computer reconstruction, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.

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

Yes

The "Intended Use / Indications for Use" section explicitly states that the PaX-500 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 structures." The "Device Description" also refers to it generating "diagnostic X-ray imaging."

No

The device description explicitly states it is an "extraoral dental digital x-ray source" and an "Xray system device based on digital X-ray imaging sensor to capture X-ray digital tomogram scanned Image". This indicates the device includes hardware components for generating and capturing X-rays, in addition to any software for image reconstruction.

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 (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device function: The PaX-500 is an X-ray system that produces images of the teeth, jaw, and oral structures. It works by transmitting X-rays through the body and capturing the resulting data. This is an in vivo diagnostic method (performed on a living organism), not an in vitro method (performed outside the body).
  • Intended Use: The intended use clearly states it's for producing images for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures. This involves imaging the patient directly.

Therefore, the PaX-500 falls under the category of medical imaging devices, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

The PaX-500 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 structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

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

OAS

Device Description

PaX-500 is an extraoral dental digital x-ray source generating diagnostic X-ray imaging from Digital Tomography, Panoramic, and Cephalometric dental X-ray modality. This Xray system device is based on digital X-ray imaging sensor to capture X-ray digital tomogram scanned Image 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray

Anatomical Site

teeth, jaw, oral structures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2, EN/IEC 61000-3-2 and EN/IEC 61000-3-3. 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.

K063773

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

§ 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.

0

Kora350

00710000

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.18.

Date: July. 30, 2008

    1. Company and Correspondent making the submission:
Name -Vatach Co., Ltd.
Address -473-4, Bora-dong, Giheung-gu
Yongin-si, Kyunggido, KOREA, 446-904
Telephone -+82-31-377-9104
Fax -+82-31-337-1882
Contact -Mr. Dong Taek, Oh
Internet -http://www.vatech.co.kr
    1. Device :
Trade/proprietary name: PaX-500
Common Name: Digital dental panoramic and cephalostat with
computed tomography x-ray system
Classification Name: X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
    1. Predicate Device :
Manufacturer: Instrumentarium Dental Inc.
Device: OP-200
510(k) Number: K063773 (Decision Date - Jan. 31. 2007)
  1. Classifications Names & Citations :

21CFR 892.1750, OAS, X-RAY, TOMOGRAPHY, COMPUTED, DENTAL Device Class2

1

5. Description :

5.1 General

PaX-500 is an extraoral dental digital x-ray source generating diagnostic X-ray imaging from Digital Tomography, Panoramic, and Cephalometric dental X-ray modality. This Xray system device is based on digital X-ray imaging sensor to capture X-ray digital tomogram scanned Image 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.

5.2 Product features

  • 1). Condition of Input
  • · Rated input voltage : AC 230V
  • · Guaranteed working voltage

-110V Mode : 100 ~120V / 220V Mode : 210 ~250V

  • · Rated input frequency : 50Hz/60Hz
  • · Insulation withstanding : below than 1.5KV cap for more than one minute

between first test and second test.

2) Capture mode

  • · Panoramic System
    • 2-1 Standard Mode
      • V Standard Panoramic
      • Hemi-Panoramic (Left and Right) >

      • Frontal Dentition

      • Sinus

      • TMJ open/Close mouth: 4 views

    • 2-2 Special Mode

      • Incisor clear

      • Orthogonal

      • V Canal clear
      • Maxillary Molar clear >

2

  • · Capture modes of Cephalometric System : Option
    • √ Latero-Lateral [Lateral Mode]
    • ✓ Posterior Anterio [PA Mode]
    • V Carpus
    • V SMV
  • · Tomography : Option
    • √ Shooting Mode : Mandible/ Maxillary/ Occlusion/ TMJ
    • ✔ Shooting Range : All kind of tooth

    • Basic Display View : View Available

    • ✓ Reference Panorama View : Available
    • √ Image : Standard viewer / Professional Viewer
    1. Indication for use :

The PaX-500 is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and crosssectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral tissue by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

    1. Comparison with predicate device :
      Vatech Value Co., Ltd., believes that the PaX-500 is substantially equivalent to the OP-200 of Instrumentarium Dental Inc.
    1. Safety, EMC and Performance Data :
      Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2, EN/IEC 61000-3-2 and EN/IEC 61000-3-3. All test results were satisfactory.
    1. Conclusions :

3

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 892.1750 and based on the information provided in this premarket notification Vatech Co., Ltd. concludes that The PaX-500 is safe and effective and substantially equivalent to predicate devices as described herein.

    1. Vatech Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
      END

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines that suggest the bird's wings and body. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

VA Tech Co., Ltd. % Mr. Dave Kim Product Compliance Manager E-WOO Technology USA, Inc. 256 North Sam Houston Pkwy E. #115 HOUSTON TX 77060

Re: K082350

Trade/Device Name: PaX-500 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: September 25, 2008 Received: September 26, 2008

Dear Mr. Kim:

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.

5

Page 2

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxx(Obstetrics/Gynecology)240-276-0115
21 CFR 894.xxx(Radiology)240-276-0120
Other240-276-0100

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 Biometrics' (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 yours.

Jorque M. Whang

Joyce M. Whang, Ph.D. 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): (၁၅ 235 ວ

Device Name: PaX-500

Indications for Use:

The PaX-500 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 structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

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)

Rozm. M. Khan

Page 1 of _1

ductive, Abdominal

510(k) Number