(71 days)
Not Found
No
The document describes a standard dental CT imaging system and does not mention any AI or ML capabilities in the device description, intended use, or performance studies.
No
This device is described as diagnostic equipment providing 3D imaging for diagnosis and treatment planning, not for therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "provides 3D imaging of dental and maxillofacial for diagnosis and treatment planning." Additionally, the "Device Description" states "Model Master3DS is diagnostic equipment."
No
The device description explicitly states it is a "Computed Tomography X-ray System" and describes hardware components like a "panoramic dental x-ray system" and a "CMOS CT Sensor". The performance studies also mention electrical, mechanical, and environmental safety testing, which are relevant to hardware.
Based on the provided information, the Master3DS 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.
- Master3DS Function: The Master3DS is an X-ray and Computed Tomography (CT) system. It uses radiation to create images of the internal structures of the dental and maxillofacial region. This is an in vivo diagnostic method, meaning it is performed on a living organism.
- No Mention of Samples: The description does not mention the collection or analysis of any biological samples.
Therefore, the Master3DS falls under the category of medical imaging devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Master3DS is a X-ray, tomography, computed, dental that provides 3D imaging of dental and maxillofacial for diagnosis and treatment planning.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
E-WOO Dental Imaging system Master3DS is a Computed Tomography X-ray System. Computed Tomography (CT) provides valuable 3-D imaging of the dental and maxillofacial structures for diagnosis and treatment planning. Uses of CT imaging include for assessment of impacted teeth, root configurations and mandibular condyle evaluation. This technology allow for 3-D imaging but at lower equipment cost, simpler image acquisition and lower patient radiation dose. Model Master3DS is diagnostic equipment which consists of panoramic dental x-ray system and computed tomography x-ray system. The panoramic dental x-ray is a system based on digital and computed tomography (CMOS CT Sensor to Capture 3D x-ray Computerized tomogram scanned image). Master3DS, the dental CT system with digital panoramic unit, provides the high quality digital image. It is not necessary to attach / detach the panoramic sensor when you capture CT images by Auto-Switching system. It is possible to capture Maxillary, mandible and whole arch by wider FOV (12 * 7). With Picasso-Trio it is not required to purchase a CT and a panoramic system each separately. It is helpful for treatments by viewing the invisible part with a 3-D CT images. The disk space for installation is no bigger than that of a general panoramic system. A clear Tomography image upto minimum 0.1mm at any directions. Drastically reduce X-Ray expose dose comparing with medical CT in consideration of patient's safety. You can set and control the Examination Program Mode with a console PC. Support more accurate diagnosis imaging than LCD as well as voice announcement function for patients and staffs. Master3DS supports the DICOM Format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Computed Tomography (CT), panoramic dental x-ray system
Anatomical Site
dental and maxillofacial structures
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 standard EN/IEC 60601-1, EN/IEC 60601-2-7, EN/IEC 60601-2-28, EN/IEC 60601-2-32 and EN/IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). 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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summary
OCT 31 2008
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Jul. 17, 2008
-
- Company and Correspondent making the submission:
Name -- E-WOO Technology Co., Ltd.
- Company and Correspondent making the submission:
Address - 1F, 4F, Yunmin Technotown, 473-4, Bora-dong, Giheung-gu, Yongin-si,
Gyeonggi-do, 449-904, Korea
Telephone - +82-31-285-6950
Fax - +82-31-286-3007
Contact - Mr. DongTaek, Oh
Internet - http://www.e-wootech.com
-
- Device :
| Trade/proprietary name | : Master3DS |
|---|---|
| Common Name | : X-ray, tomography, computed, dental |
| Classification Name | : X-ray, tomography, computed, dental |
-
- Predicate Device :
| Manufacturer | : Imaging Sciences International, Inc. |
|---|---|
| Device | : i-CAT |
| 510(k) Number | : K061284(Decision Date - Jul. 3. 2006 |
-
- Classifications Names & Citations :
21CFR 892.1750, OAS, X-ray, tomography, computed, dental, Class2
- Classifications Names & Citations :
- Description :
5.1 General
E-WOO Dental Imaging system Master3DS is a Computed Tomography X-ray
E-WOO Technology Co., Ltd.
1
System. Computed Tomography (CT) provides valuable 3-D imaging of the dental and maxillofacial structures for diagnosis and treatment planning. Uses of CT imaging include for assessment of impacted teeth, root configurations and mandibular condyle evaluation. This technology allow for 3-D imaging but at lower equipment cost, simpler image acquisition and lower patient radiation dose.
Model Master3DS is diagnostic equipment which consists of panoramic dental x-ray system and computed tomography x-ray system. The panoramic dental x-ray is a system based on digital and computed tomography (CMOS CT Sensor to Capture 3D x-ray Computerized tomogram scanned image)
5.2 Product features
- · Master3DS, the dental CT system with digital panoramic unit, provides the high quality digital image.
- · It is not necessary to attach / detach the panoramic sensor when you capture CT images by Auto-Switching system.
- · It is possible to capture Maxillary, mandible and whole arch by wider FOV (12 * 7).
- · With Picasso-Trio it is not required to purchase a CT and a panoramic system each separately.
- · It is helpful for treatments by viewing the invisible part with a 3-D CT images.
- · The disk space for installation is no bigger than that of a general panoramic system.
- · A clear Tomography image upto minimum 0.1mm at any directions
- · Drastically reduce X-Ray expose dose comparing with medical CT in consideration of patient's safety
- · You can set and control the Examination Program Mode with a console PC
- · Support more accurate diagnosis imaging than LCD as well as voice announcement function for patients and staffs
- · Master3DS supports the DICOM Format
- ഗ Indication for use :
The Master3DS is a X-ray, tomography, computed, dental that provides 3D imaging of dental and maxillofacial for diagnosis and treatment planning.
- Comparison with predicate device : ଦ
Image /page/1/Picture/19 description: The image is a black and white abstract design. The image is mostly white, with black shapes scattered throughout. The black shapes are irregular and vary in size.
2
E-WOO Technology Co., Ltd., believes that the Master3DS is substantially equivalent to the i-CAT of Imaging Sciences International, Inc.,
- 7 Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-2-7, EN/IEC 60601-2-28, EN/IEC 60601-2-32 and EN/IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory.
9. Conclusions :
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 Master3DS is safe and effective and substantially equivalent to predicate devices as described herein.
-
- E-WOO Technology Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA,
END
- E-WOO Technology Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA,
E-WOO Technology Co., Ltd.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 31 2008
E-WOO Technology Co., Ltd. % Mr. Vincent Lee President E-WOO Technology USA, Inc. 256 North Sam Houston Pkwy E. #115 HOUSTON TX 77060
Rc: K082410
Trade/Device Name: X-ray, tomography, computed, dental/Master3DS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: August 17, 2008 Received: August 21, 2008
Dear Mr. Lee:
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.
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" (21CFR 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/cdrh/industry/support/index.html.
Sincerely vours,
lope M. 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):
KO82410
Device Name: X-ray, tomography, computed, dental /Master3DS
Indications for Use:
The Master3DS is a X-ray, tomography, computed, dental that provides 3D imaging of dental and maxillofacial for diagnosis and treatment planning.
Over-The-Counter Use_ Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (Part 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)
Helus Remen
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 82410 ් (1)(k) Number
Page 1 of _1
Image /page/5/Picture/12 description: The image shows the number 28 in a simple, bold font. The numbers are slightly separated and have a classic, almost typewriter-like appearance. The background is plain and light, which makes the numbers stand out clearly.