COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO
Device Facts
| Record ID | K090991 |
|---|---|
| Device Name | COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO |
| Applicant | E-Woo Technology |
| Product Code | JAK · Radiology |
| Decision Date | Oct 9, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
Indications for Use
The Picasso-Duo is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images(optionally with panoramic) for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Device Story
Picasso-Duo is a combined digital panoramic and computed tomography (CT) dental X-ray system. It captures 3D X-ray transmission data using a CMOS CT sensor; data is reconstructed by computer into cross-sectional images of dental and maxillofacial structures. The system features an auto-switching mechanism to transition between panoramic and CT modes without sensor detachment. Operated by dental professionals via a console PC, the device provides 3D visualization of previously invisible structures to assist in diagnosis and treatment planning for impacted teeth, root configurations, and mandibular condyle evaluation. Output is displayed as digital images supporting DICOM format. The device is intended for use in clinical dental settings, offering a smaller footprint than separate systems and supporting wider fields of view (15x15).
Clinical Evidence
Bench testing only. Performance and safety were validated through electrical, mechanical, and environmental testing in accordance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-2-44. EMC testing was conducted per IEC 60601-1-2. All results were satisfactory.
Technological Characteristics
Combined panoramic and CT X-ray system; CMOS CT sensor; 15x15 FOV; DICOM support; console PC control; voice announcement function. Standards: IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 60601-2-44, and IEC 60601-1-2 (EMC).
Indications for Use
Indicated for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures in patients requiring cross-sectional or panoramic imaging.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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K070991
# 510(k) Summary
OCT - 9 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: _Mar. 25, 2009
1. Company and Correspondent making the submission:
Name - E-WOO Technology Co., Ltd.
Address - 1F, 4F, Yunmin Technotown, 473-4, Bora-dong, Giheung-gu, Yongin-si,
Gyeonggi-do, 446-904, Korea
Telephone -- +82-31-285-6950
Fax -- +82-31-286-3007
Contact - Mr. DongTaek, Oh
Internet - http://www.e-wootech.com
- 2. Device :
| Trade/proprietary name | : Picasso-Duo |
|------------------------|------------------------------------|
| Common Name | : Computed tomography x-ray system |
| Classification Name | : Computed tomography x-ray system |
- 3. Predicate Device
| Predicate Device A: | |
|---------------------|-------------------------------------------|
| Manufacturer | : VATECH Co., Ltd. |
| Device | : PaX-500 |
| 510(k) Number | : K082350 (Decision Date - Oct. 10. 2008) |
| Predicate Device B: | |
| Manufacturer | : E-WOO Technology Co., Ltd. |
| Device | : EPX-Impla: Picasso-Trio |
| 510(k) Number | : K070658 (Decision Date - Apr. 5. 2007) |
E-WOO Technology Co., Ltd.
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## 4. Classifications Names & Citations :
21CFR 892.1750, OAS, Computed tomography x-ray system, Class2
## 5. Description :
### 5.1 General
E-WOO Dental Imaging system Picasso-Duo 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 Picasso-Duo 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
- · Picasso-Duo, 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 (15 * 15).
- 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
- · 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
- · Picasso-Duo supports the DICOM Format
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510(k) Submission - Picasso-Duo
#### ട Indication for use :
The Picasso-Duo is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images(optionally with panoramic) for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
#### Comparison with predicate device : ಲ
E-WOO Technology Co., Ltd., believes that the Picasso-Duo is substantially equivalent to the EPX-Impla of E-WOO Technology Co., Ltd. and PaX-500 of VATECH Co., Ltd.
7 Safety, EMC and Performance Data :
> Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 and IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. 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 Picasso-Duo is safe and effective and substantially equivalent to predicate devices as described herein.
- 10. 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.
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Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, with three curved lines emanating from a central point.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
# OCT - 9 2009
E-Woo Technology c/o Mr. Vincent Lee E-Woo Technology USA, Inc. 256 North Sam Houston Pkwy. E, Suite 115 HOUSTON TX 77060
Re: K090991
Trade/Device Name: Computed tomography x-ray system /Picasso-Duo Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 22, 2009 Received: September 24, 2009
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 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); medical device reporting (reporting of medical
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device-related 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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number(if known):
K090991
Device Name: Computed tomography x-ray system /Picasso-Duo
Indications for Use:
The Picasso-Duo is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images(optionally with panoramic) for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Prescription Use AND/OR Over-The-Counter Use (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)
Division of
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(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number
