(219 days)
Not Found
No
The description focuses on standard digital X-ray image acquisition and processing techniques, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No
The device is solely intended for diagnostic imaging and does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to produce diagnostic quality radiographic images" and that the cephalometric system produces images "that maybe used in orthodontic diagnosis procedures."
No
The device description clearly states it is a "dental panoramic and cephalometric device which is digital X-ray imaging device" and includes hardware components like an "X-ray generator and Sensor for panoramic and cephalometric at Rotation unit which are supported by Main frame and Column." While software is used for image processing and display, the core device is a hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a dental panoramic and cephalometric X-ray machine. It acquires digital 2D X-ray images of the teeth, jaw, and TMJ areas by exposing the patient to X-rays.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It directly images the patient's anatomy.
Therefore, based on the provided information, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Point 500 HD/500C HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures.
Point 500 HD/500C HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The Point 500 HD/500C HD is a dental panoramic and cephalometric device which is digital X-ray imaging device. It is intended for dental radiographic examinations of teeth, jaw and TMJ areas by exposing X-ray and then converts this information to the digital signals to acquire images. High-defined images are provided by controlling acquired image with computer and this is used to obtain panoramic and cephalometric images for dental purpose. This equipment is equipped with an X-ray generator and Sensor for panoramic and cephalometric at Rotation unit which are supported by Main frame and Column. When rotation unit is rotating around the patient's teeth and jaw for acquiring panoramic image, X-ray exposes and sensor detects the data from X-ray generator. Detected data from each frame is transferred to PC, and combined together to display panoramic image on PC screen by installed software on PC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw and TMJ areas
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 standards EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, and EN/IEC 60601-2-32 were 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.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for PointNix. The logo includes a stylized flower-like graphic to the left of the word "SMART". To the right of "SMART" is the phrase "Digital Leader" above the word "PointNix". The word "PointNix" is in a bold, sans-serif font.
Twin Tower 1. 212-1. Kuro-Dong, Kuro-Ku, Seoul, Korea -854-8315 / Fax: 82-2-839-4973
510(K) SUMMARY
JAN 2 4 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is K121800. Date: January 17, 2013
1. Submitter's Identification:
PointNix Co., Ltd. #302~303, 3F, Ace Twin Tower 1, 212-1, Kuro-Dong, Kuro-Ku, Seoul, Korea Tel: +82-2-854-8315(ext. 309) Fax: +82-2-839-4973 E-mail: support@pointnix.com info@pointnix.com
2. Name of the Device:
Dental Digital X-ray Imaging Device models Point 500HD and Point 500C HD.
3. Common or Usual Name:
Usual Name : Dental Digital X-ray Imaging System Classification : Class II 21 CFR 872.1800 System, x-ray, extraoral source, digital Class Code : MUH
4. Predicate Device Information:
The Yoshida Dental MFG. Co., LTD.: Panoura 18S - K111231
5. Device Description:
The Point 500 HD/500C HD is a dental panoramic and cephalometric device which is digital X-ray imaging device. It is intended for dental radiographic examinations of teeth, jaw and TMJ areas by exposing X-ray and then converts this information to the digital signals to acquire images. High-defined images are provided by controlling acquired image with computer and this is used to obtain panoramic and cephalometric images for dental purpose. This equipment is
1
Image /page/1/Picture/1 description: The image shows the logo for PointNix. The logo includes a stylized graphic to the left of the text. Above the word "PointNix" is the phrase "Digital Leader" in a smaller font.
3F, Ace Twin Tower 1, 212-1, Kuro-Dong, Kuro-Ku, Seoul, Korea Tel: 82-2-854-8315 / Fax: 82-2-839-4973
equipped with an X-ray generator and Sensor for panoramic and cephalometric at Rotation unit which are supported by Main frame and Column. When rotation unit is rotating around the patient's teeth and jaw for acquiring panoramic image, X-ray exposes and sensor detects the data from X-ray generator. Detected data from each frame is transferred to PC, and combined together to display panoramic image on PC screen by installed software on PC.
6. Intended Use:
Point 500 HD/500C HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures. .
7. Comparison to Predicate Devices:
| Characteristic | Model Proposed :
Point 500HD, Point 500C
HD | Predicated :
Panoura 18S |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | - | K111231 |
| Intended Use | Point 500 HD/500C HD
which is the dental
panoramic/panoramic and
cephalometric device is
intended to produce
diagnostic quality
radiographic images by
acquiring digital 2D X-ray
images. The cephalometric
system produces
cephalomertric radiographic
images that maybe used in
orthodontic diagnosis
procedures. | The Panoura 18S dental
panoramic and
cephalometric device is
intended for dental
radiographic examinations of
teeth, jaw and TMJ areas by
producing conventional 2D
X-ray images as well as X-
ray projection images. The
device must only be
operated and used by
dentist and other legally
qualified professionals. |
| Tube Voltage | 50-90kV | 58-82kV |
| Tube Current | 4-16mA | 2-10mA |
| Focal Spot Size | 0.5 x 0.5 mm | 0.5 x 0.5 mm |
| Scan Time | Only Panorama Mode(Point
500HD) : 16sec,
Added cephalo Mode(Point
500C HD) : 0.8sec | Panorama Mode: 16sec
Cephalo Mode: 10sec |
2
Image /page/2/Picture/1 description: The image shows the logo for PointNix. The logo includes a stylized flower-like graphic to the left of the word "SMART". To the right of "SMART" is the word "PointNix", with the words "Digital Leader" above it. The logo is black and white.
3F, Ace Twin Tower 1, 212-1, Kuro-Dong, Kuro-Ku, Seoul, Korea
Tel: 82-2-854-8315 / Fax: 82-2-839-4973
Statement of substantial equivalence 8.
The characteristics of the Point 500HD/500C HD are similar to those of the Panoura 18S (K111231) listed below:
- Intended use
- · Operating characteristics
- · Radiation
Difference between Point 500HD/500C HD and Panoura 18S (K111231) is listed below:
- · Detector type
This difference of detector does not raise any new safety or effectiveness concerns compared to the Panoura 18S (K111231).
9. Discussion of Non-Clinical Tests Performed:
Electrical, mechanical, environmental safety and performance testing according to standards EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, and EN/IEC 60601-2-32 were performed, and EMC testing was conducted in accordance with a standard EN/IEC 60601-1-2. All test results were satisfactory.
Discussion of Clinical Tests Performed: 10.
Not Required
11. Conclusions:
The PointNix Co., model Point 500HD and Point 500C HD have been developed and validated according to all applicable standards. Evaluations have proven that the system is safe and effective for the intended use. Risk analysis and safety certifications reveal that there is no new safety issues associated with this system as compared with the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle with its wings spread. The eagle is composed of three curved lines, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2013
PointNix Company, Limited C/O Mr. Jigar Shah MDI Consultants, Incorporated #302~303, 3F, Ace Twin Tower 1, 212-1, Kuro-Dong Kuro-Ku, Seoul, Korea
Re: K121800
Trade/Device Name: Dental Digital X-ray imaging system point 500 HD and point 500C HD Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: II Product Code: MUH Dated: January 10, 2013 Received: January 15, 2013
Dear Mr. Shah:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may 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.
4
Page 2 - Mr. Shah
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 devicerelated 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.fda.gov/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,
Kwame Q. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image contains a logo for a company called "PointNix". The logo features a stylized graphic to the left of the text, with the word "SMART" underneath. Above the company name, the words "Digital Leader" are printed in a smaller font. The logo is simple and modern, with a focus on the company name.
Twin Tower 1, 212-1, Kuro-Dong, Kuro-Ku, Seoul, Korea 82-2-854-8316 / Fax: 82-2-839-
Section 2: Indications for Use
Page 1 of 1
K 21 800 510(k) Number (if known):
Device Name: PointNix Co., Ltd. Dental Digital X-ray Imaging System Point 500 HD and Point 500C HD
Indications For Use:
Point 500 HD/500C HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 807 Subpart C)
(Please do not write below this Line-Continue on another PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner DDS, MA-115:22:50 -05'00'
ﻟﺴﻤﺮ
Division Sign-Off) 'ivision of Anesthesiology, General Hospital ifection Control, Dental Devices
510(k) Number:
2-1