(57 days)
Not Found
No
The description focuses on the hardware and basic operation of a portable X-ray system, with no mention of AI, ML, or advanced image processing features.
No
The device is described as an X-ray source for producing diagnostic images, which indicates a diagnostic rather than therapeutic purpose.
Yes
The device explicitly states its purpose is "for producing diagnostic x-ray images" and "to diagnose of tooth and jaw." It is also referred to multiple times as a "diagnostic x-ray system."
No
The device description clearly outlines a physical hardware system including an X-ray generator, controller, beam limiting device, battery, and other electrical components. It is a portable dental X-ray system, not a software-only 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 taken from the human body. The description clearly states that this device is an extraoral x-ray source used to produce diagnostic images of the tooth and jaw on the patient. It does not involve analyzing biological samples.
- The device's function is to generate and control X-rays for imaging. This is a form of medical imaging, not in vitro diagnostics.
The device is a medical imaging device, specifically a portable dental X-ray system.
N/A
Intended Use / Indications for Use
The Portable X-ray System (Model: DIOX-602, PROX) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
Product codes
EHD
Device Description
The Portable X-ray System (Model: DIOX-602, PROX) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger.
The Portable X-ray System generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor).
The Portable X-ray System (Model: DIOX-602, PROX) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral xray source for producing diagnostic x-ray images using intra-oral image receptors.
Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: DIOX-602, PROX) provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Tooth and jaw
Indicated Patient Age Range
Adult and pediatric subjects
Intended User / Care Setting
Trained dentists and dental technicians
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)
The result of bench testing and clinical evaluation indicates that the subject device is as safe and effective as the predicate devices.
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
K082 167
Image /page/0/Picture/1 description: The image contains the word "DigiMed" in a stylized font. To the left of the word is an oval shape that is divided into sections of varying shades of gray and black. The text is in a bold, slightly italicized font, giving it a modern and professional appearance. The overall composition is simple and clean, with a focus on the text and the abstract oval shape.
SEP 2 6 2008
5 510(k) Summary
5.1 Company and Correspondent Making the Submission:
| Date Prepared: | June 16, 2008 |
|---|---|
| Name: | DIGIMED Corporation |
| Address: | #715, World Meridian Venture Center II, 426-5 Gasan-Dong |
| Gumcheon-Gu, Seoul, 153-803, Korea | |
| Tel: | +82-2-2025-8780 |
| Fax: | +82-2-2025-8782 |
| E-mail: | digi-med@hanmail.net |
| Contact: | Youngbae Kwon, Managing Director |
: 上一篇:
5.2 US Agent for FDA Contact:
| Name: | Shin Kuk Yoo |
|---|---|
| Company: | LSK BioPartners, Inc. |
| Address: | 215 S. State St. STE100B |
| Salt Lake City, Utah 84111 | |
| Tel: | 801-303-7440 (Ext. 202) |
| Fax: | 801-303-7455 |
| Email: | skyone@LSKBioPartners.com |
5.3 Device Information:
. ...
.
| Proprietary-Trade Name: | Portable X-Ray System (Models: DIOX-602, PROX) |
|---|---|
| Classification Name: | Extraoral Source X-Ray System: EHD, Class II per regulation 21CFR 872.1800 |
| Common/Usual Name: | Portable X-Ray System |
| Manufacturer: | GENORAY Co., Ltd. |
|---|---|
| Device: | Portable X-Ray System (Model: PORT-X II) |
| Classification: | Extraoral Source x-Ray System: EHD, Class II per regulation 21CFR 872.1800 |
| 510(k) Number: | K063121 (Decision Date: Jan. 11, 2007) |
:
1
5.5 Indications for Use (Intended Use):
The Portable X-ray System (Model: DIOX-602, PROX) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
5.6 Description of Device
The Portable X-ray System (Model: DIOX-602, PROX) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger.
The Portable X-ray System generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor).
The Portable X-ray System (Model: DIOX-602, PROX) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral xray source for producing diagnostic x-ray images using intra-oral image receptors.
Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: DIOX-602, PROX) provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.
5.7 Safety and Effectiveness, Comparison to Predicate Device:
The result of bench testing and clinical evaluation indicates that the subject device is as safe and effective as the predicate devices.
5.8 Safety, EMC and Performance Data:
The portable x-ray system, DIOX-602 and PROX, will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32. All required documents and reports will be submitted to the appropriate oversight agency to establish compliance with the applicable requirements.
EMS testing was conducted by EMC Compliance Co., Ltd. for DIOX-602 and SGS Testing Korea Co., Ltd. for PROX in accordance with Standard EN/IEC 60601-1-2. All test results were satisfactory.
2
5.9 Substantial Equivalence Chart
| Company | GENORAY Co. | DIGIMED Corp. | |
|---|---|---|---|
| Model | PORT-X II | DIOX-602 | PROX |
| 510(k) No | K063121 | New | |
| Energy source | Rechargeable 22.2V | ||
| DC Lithium Polymer | |||
| battery pack | Rechargeable 24V, DC Lithium Polymer Battery pack | ||
| Expose time | 0.01-2.0 seconds | ||
| 0.01 increments | 0.01-1.6 seconds, 0.01 increments | ||
| Time accuracy | $\pm$ (10%+1ms) | $\pm$ (10%+1ms) | |
| mA | 2mA fixed | 2mA fixed | |
| kVp | 60kV fixed | 60kV fixed | |
| Wave form | Constant Potential (DC) | Constant Potential (DC) | |
| Safety, EMC and | |||
| performance | IEC 60601-1, IEC 60601- | ||
| 2-7 | |||
| IEC 60601-2-28, | |||
| IEC 60601-2-32 | IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28, | ||
| IEC 60601-2-32 | |||
| Source to skin | |||
| distance | 20cm | 20cm | |
| Cone diameter | 7Cm | 6.5 Cm | 6 Cm |
| User Interface | Exposure time: up, down. | ||
| Selection buttons of parts | |||
| of teeth, adult and child, | |||
| film and sensor with | |||
| display. | Exposure time: up, down. | ||
| Two buttons for modes | |||
| and selection of parts of | |||
| teeth, adult and child, | |||
| film and sensor with | |||
| display. | Exposure time: up, down. | ||
| Selection | |||
| buttons of parts of | |||
| teeth, adult and child, | |||
| film and sensor with | |||
| display. | |||
| Exposure switch | Control panel and | ||
| remote controller | Control panel and remote controller | ||
| Tube head | |||
| mounting | Yes | Yes | |
| Intended use | Intended to use by trained dentists and dental technicians as an extra-oral x-ray | ||
| source for producing diagnostic x-ray images using intra-oral image receptors or | |||
| film. It is intended to use for both adult and pediatric subjects. |
5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided the above comparison table, the DIGIMED Corporation concludes that the portable X-ray System (Model: DIOX-602, PROX) is safe and effective and substantially equivalent to the predicate device as described above.
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a modern, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2008
DIGIMED Corporation % Mr. Shin Kuk Yoo Business Development Manager LSK BioPartners, Inc. 215 S. State Street, STE 100B SALT LAKE CITY UT 84111
Re: K082167
Trade/Device Name: Portable x-ray system (Models: DIOX-602, PROX) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: July 29, 2008 Received: July 31, 2008
Dear Mr. Yoo:
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 ffor 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.
4
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 |
| 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 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/odrh/industry/support/index.html.
Sincerely yours.
hope Mr. 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
5
Indications for Use
510(k) Number (if known): K082167
Device Name: Portable x-ray system (Models: D1OX-602, PROX) Indications for Use:
The Portable X-ray System (Model: DIOX-602, PROX) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hw Lewis
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number