(102 days)
Not Found
No
The summary describes a standard dental X-ray system and does not mention any AI or ML capabilities, image processing, or details about training/test sets typically associated with AI/ML devices.
No
The device is described as a "diagnostic extraoral dental X-ray system" used for "taking diagnostic extraoral dental X-rays." Its purpose is to acquire images for diagnosis, not to treat a condition.
Yes
The device is used for "taking diagnostic extraoral dental X-rays," indicating its role in diagnosis.
No
The device description explicitly states it is a "Cordless Portable Dental X-ray System operated by battery-powered and hand-held dental x-ray machine," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device is an X-ray system used to take images of the teeth and surrounding structures in vivo (within the body) for diagnostic purposes.
The description clearly states it's a "Cordless Portable Dental X-ray System" used for "taking diagnostic extraoral dental X-rays using digital sensors." This is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The ADX4000-L, DX3000-L Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using digital sensors.
Product codes
MUH
Device Description
The ADX4000-L, DX3000-L are Cordless Portable Dental X-ray System operated by battery-powered and hand-held dental x-ray machine, This is a prescription device that can be used on pediatric and adult patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays
Anatomical Site
extraoral dental
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
trained and qualified dentists or dental technician
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)
Bench testing was also conducted to demonstrate performance specifications.
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
§ 872.1800 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.
0
KO83532
MAR 1 0 2009
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| Submitter Information: | Dexcowin Co., Ltd
#606, Woolim Lions Valley II 680, Gasan-dong,
Geumcheon-gu, Seoul, Korea |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Claude Yang (Yang Ho Dong)
Onbix Corporation
#708 Le-Meilluer Town, 837-19 Yeuksam-dong
Gangnam-gu, Seoul, Korea
Tel: +82-2-5663360 / Fax: +82-2-62803360
Email: onbix@naver.com |
Nov 25, 2008 Date Summary Prepared:
Device Name: Trade Name(s): ADX4000-L, DX3000-L Classification Name: X-Ray, Extraoral Source, Digital Radiology Panel: Product Code: MUH
Predicate Device Information: K070811 DexcoWinA ADX4000
Device Description:
The ADX4000-L, DX3000-L are Cordless Portable Dental X-ray System operated by battery-powered and hand-held dental x-ray machine, This is a prescription device that can be used on pediatric and adult patients.
Intended Use:
The ADX4000-L, DX3000-L Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using digital sensors.
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
*indications for use *technological characteristics *performance properties
Summary of Testing:
This device meets consensus standards IEC 601-1, 60601-1-2, 60601-1-2, 60601-2-7 etc. Bench testing was also conducted to demonstrate performance specifications.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble a person with outstretched arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2009
DEXCOWIN Co., Ltd. % Mr. Claude Yang, CEO Onbix Corporation #708 Le-Meilleur Town, 837-19 Yeuksam-dong, Gangnam-gu Seoul, 135-937 SOUTH KOREA
Re: K083532
Trade/Device Name: ADX4000-L, DX30000-L Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH
Dated: February 10, 2009
Received: February 12, 2009
Dear Mr. Yang:
We have reviewed vour 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.
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 os 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 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Manufactures, 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.suppot/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
085532
510(k) Number (if known): 1
Device Name: ADX4000-L, DX3000-L
Indications for Use:
The ADX4000-L, DX3000-L Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using digital sensors.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jules Renner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number