(49 days)
No
The document describes a standard portable X-ray system and does not mention any AI or ML components or functionalities.
No
The device is described as an "extraoral x-ray source for producing diagnostic x-ray images," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for producing diagnostic x-ray images." Also, the "Device Description" mentions "This equipment generates and controls X-ray in order to diagnose of tooth and jaw."
No
The device description clearly states it is a "Portable X-Ray System" with hardware components like an X-ray tubehead, controls, power source, and battery, assembled into a hand-held enclosure. This indicates it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce diagnostic x-ray images using intraoral image receptors for diagnosing tooth and jaw conditions. This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description: The device is an X-ray system that generates and controls X-rays to create images. This is a medical imaging device, not a device for testing biological samples.
- Operating Principle: The operating principle involves generating X-rays to create images on a receptor, which is characteristic of medical imaging equipment.
- Anatomical Site: The device is used on the tooth and jaw, which are parts of the patient's body.
- Input Imaging Modality: The input is X-ray, a form of radiation used for imaging the body.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state. This device operates on the human body to create images.
N/A
Intended Use / Indications for Use
"AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an 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
"AnyRay" is a wireless Portable X-Ray System that operates on DC22.5V supplied by a rechargeable Lithum-Polymer battery pack. The X-ray tubehead, X-ray controls and power source are assembled into a single hand-held enclosure. The Package includes DC adaptor and Chair (Option) This equipment generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of xray generator, controller, beam limiting device and chair (Option). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which (Openatifs primelpes in this x-ray images on receptor.
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 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)
Not Found
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
AUG 2 1 2008
EXHIBIT 2 510(k) Summary
E-Woo Technology Co., Ltd. 1F/4F/5F, Yunmin Technotown, 473-4, Bora-Dong, Giheung-Gu, Yongin-Si, Gyeonggi-Do, Korea 446-904 Tel: 82-31-899-7967 Fax: 82-31-286-3007 Taewoo Kim, President & CEO January 15, 2008
-
Identification of the Device: Proprietary-Trade Name: Portable X-Ray System "AnyRay" Classification Name : Unit, X-Ray, Extraoral with Timer / Product Code EHD Common/Usual Name: Portable X-Ray System
-
Equivalent legally marketed device: This product is similar in design and identical in function to Portable Dental X-Ray System Model "NOMAD" (K051795, Aribex, Inc)
-
Indications for Use (intended use):
"AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-fay source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
- Description of the device:
"AnyRay" is a wireless Portable X-Ray System that operates on DC22.5V supplied by a rechargeable Lithum-Polymer battery pack. The X-ray tubehead, X-ray controls and power source are ssembled into a single hand-held enclosure. The Package includes DC adaptor and Chair (Option) This equipment generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of xray generator, controller, beam limiting device and chair (Option). Operating principle is that x-ay generated by high voltage electricity into x-ray tube, which (Openatifs primelpes in this x-ray images on receptor.
| Feature | Predicate:
(NOMAD TM Dental X-Ray System, K051795) | New Device
Portable X-Ray System “AnyRay” |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Manufacturer | Aribex, Inc. | E-Woo Technology Co., Ltd. |
| Intended Use | Both systems are intended as extraoral x-ray sources to be used with intraoral image receptors
for diagnostic imaging by dentists or dental technicians. | |
| Body Size and
Weight | 13"L x 11.5H x 5.5"W/ 8.5lbs | 8.6"L x 6.0"H x 5.8"W/ 5.3lbs |
| Chair(Option)
and Weight | - | 18.8"L x 66.6"H x 27.0"W/76.1lbs |
| Source to skin
distance | 20cm | 20cm |
| | | |
| Cone diameter | 6cm | 6.5cm |
| User Interface | Up-down buttons for exposure time
selection, with timer display | Up-down buttons for exposure time
selection, with timer display |
| Backscatter
radiation
protection | 6.75" dia. Pb-filled acrylic plastic scatter
shield | Circular scatter shield |
| Exposure
switch | On tubehead assembly/control panel | On tubehead assembly/control panel |
| Tubehead
mounting | Handheld | Handheld |
| Energy Source | Rechargeable 14.4V DC NiCd battery pack | Rechargeable 22.5V DC Lithum-Polymer
battery pack. |
| Exposure Time | 0.01 – 0.99 seconds in 0.01 increments | 0.06 s ~ 2.0 s seconds in 0.01 increments |
| Time Accuracy | ± (10% + 1ms) | ± (10% + 1ms) |
| mA | 2.3mA Fixed | 2 mA(Fixed) |
| kVp | 60kVp Fixed | 60 kVp(Fixed) |
| Waveform | Constant Potential(DC) | Constant Potential(DC) |
| Duty Cycle | 1:60 | 1:60 |
| Electrical
Safety
Standards | IEC60601-1, UL60601-1, EN60601-1 | IEC60601-1, EN60601-1 |
| EMI Standards | IEC 60601-1-2 | IEC 60601-1-2 |
| Performance
Standard | 21 CFR 1020.30, 1020.31
IEC60601-1-3
IEC60601-2-7 | IEC60601-1-3, IEC60601-2-7
IEC60601-2-28, IEC60601-2-32 |
| Biocompatibility | - | Not applicable (No direct, indirect contact
with patient) |
-
- Safety and Effectiveness, comparison to predicate device
1
6. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification E-Woo Technology Co.,Ltd. concludes that the Portable X-Ray System "AnyRay" 's safety and effectiveness are substantially equivalent to predicate devices (NOMAD™ Dental X-Ray System (K051795, Aribex, Inc)) as described herein.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe. The figure is composed of three curved lines, and the globe is represented by a series of wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2008
E-Woo Technology Company, Ltd. % Mr. Tamas Borsai Responsible Third Party Official TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K081899
Trade/Device Name: "AnyRay" Portable X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: August 7, 2008 Received: August 11, 2008
Dear Mr. Borsai:
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.
3
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 vours.
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known) :
Device Name : Portable X-Ray System "AnyRay"
Indications For Use : "AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an 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 _ v (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)
Page 1 of 1
Agnih Whang
(Division Sign-Off)
nivision of Reproductive, Abdominal and Radiological Devices 510(k) Number
7/39