(34 days)
No
The summary describes a standard digital x-ray imaging system and does not mention any AI or ML components or functionalities.
No
The device is described as an "Intra-oral Imaging System" intended for diagnostic use by dentists to collect and process dental x-ray photons for viewing and manipulation. Its purpose is to aid in diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the system's output "may be stored, viewed, and manipulated for diagnostic use by dentists." This explicitly indicates a diagnostic purpose.
No
The device description explicitly lists hardware components: "Image interface box (Read-out Box)" and "X-ray sensor".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The "HDS" Intra-oral Imaging System collects dental x-ray photons and converts them into digital images for diagnostic use by dentists. This process involves imaging the inside of the mouth using external radiation, not analyzing samples taken from the body.
The device is a medical imaging device, specifically for dental radiography.
N/A
Intended Use / Indications for Use
"HDS" Intra-oral Imaging System is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Product codes
90 MUH
Device Description
The Intra-oral image system (HDS) is a device for digital intra oral X-rays imaging. It is fully USB compliant and can be plugged in any when computer is turned on.
- Intra-oral image system (HDS) block diagram
- PC
- · Image interface box (Read-out Box)
- · X-ray sensor
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Intra-oral, dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists
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)
Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
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 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
EXHIBIT 2 510(k) Summary VATECH
OCT 0 4 2004
Value Added Technology Co., Ltd. 75-11, Seokwoori, Dongtanmyun, Hwasungsi, Kyunggido, 445-811, Korea Tel: 82-31-377-9104 Fax: 82-31-377-1882 Chang Joon Ro, President & CEO July 29, 2004
-
- Identification of the Device: Proprietary-Trade Name: "HDS" Intra-oral Imaging System Classification Name: Extraoral source x-ray system, Product Code 90 MUH Common/Usual Name: Intra-oral digital x-ray sensor
-
- Equivalent legally marketed device: This product is similar in design and identical in function to the Suni Intraoral Imaging System (K021718, Suni Imaging Microsystems Inc.)
-
- Indications for Use (intended use): Indicated for intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
-
- Description of the device: The Intra-oral image system (HDS) is a device for digital intra oral X-rays imaging. It is fully USB compliant and can be plugged in any when computer is turned on.
- Intra-oral image system (HDS) block diagram
- PC
- · Image interface box (Read-out Box)
- · X-ray sensor
Image /page/0/Figure/12 description: The image shows a diagram of an X-ray sensor setup. The setup includes a computer with a display, an image interface box, a sensor cable, and a sensor. The computer is connected to the image interface box via a USB cable, and the image interface box is connected to the sensor via the sensor cable. The diagram labels each component of the setup.
1
-
- Safety and Effectiveness, comparison to predicate device:
| Feature | Predicate: Suni Intraoral Imaging
System (K021718) | Intraoral Imaging System
(HDS) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intra-oral Imaging System is
intended to collect dental x-ray
photons and convert them into
electronic impulses that may be
stored, viewed, and manipulated
for diagnostic use by dentists. | SAME |
| Computer interface | USB (USB version not specified) | SAME, Specification 2.0 |
| Pixel Matrix | 271,000, 462,000, 1.26 M, or 1.8
M pixels, depending on model | 650,000 pixels (688 × 944
pixel) |
| Pixel Size | 22.5 or 45 um (depending on
model) | 35 um |
| Active Area | 26.8 x 21.6 mm
32.7 x 20.6 mm
36.8 x 26.6 mm
36.8 x 26.6 mm | 24.08 mm x 33.04 mm |
| External Dimensions | 32.5 x 26.4 mm
37.8 x 24.7 mm
43.0 x 31.8 mm
43.0 x 31.8 mm
Thickness 3.2 mm | 29 × 41 mm
Thickness 3.5 mm |
| Spatial Resolution | 12 lp/mm (Standard res model) | 14 lp/mm |
| Applicable PC | Computer requirements not
specified. | -Software: Pentium 3,1 GHz
-Memory size: 128 MB
-Hard disk: 10GB
-VGA; 1024x768x24 bit
-Other: Window XP, Serial
USB port |
-
- Testing information and Conclusion
In all material respects, the "HDS" Intra-oral Imaging System is substantially equivalent to Suni Intraoral Imaging System (K021718, Suni Imaging Microsystems Inc.) Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
- Testing information and Conclusion
2
Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized bird or human figure with three horizontal lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 4 - 2004
VATECH Value Added Tech., Co., Ltd. % Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates 'PO Box. 7007 DEERFIELD IL 60015
Re: K042372 Trade/Device Name: "HDS" Intra-Oral Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH
Dated: August 30, 2004 Received: September 13, 2004
Dear Mr. Kamm:
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 (Premarket Approval), 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.
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.
3
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 premated 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.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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K042372
"HDS" Intra-oral Imaging System Device Name:
Indications For Use: "HDS" Intra-oral Imaging System is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Prescription Use X (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)
David A. Syverson
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number .
Page 1 of 1