PICASSO MASTER, ECT AND MASTER 3D

K081847 · E-Woo Technology · JAK · Aug 21, 2008 · Radiology

Device Facts

• Record ID: K081847
• Device Name: PICASSO MASTER, ECT AND MASTER 3D
• Applicant: E-Woo Technology
• Product Code: JAK · Radiology
• Decision Date: Aug 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Picasso-Master also known as ECT and Master3D" is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission from the same axial plane taken at different angles. It provides diagnostic details of the anatomics structures for surgical planning of oral and maxillofacial area by acquiring of the matomal image sequences lot the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray technicians.

Device Story

Picasso-Master (also ECT/Master3D) is a computed tomography (CT) X-ray system. It uses a CMOS-CT sensor and a cone-beam X-ray source to acquire 360-degree rotational image sequences of the head and neck. The device performs computer reconstruction of X-ray transmission data from multiple angles to generate cross-sectional images. Operated by physicians, dentists, or X-ray technicians in a clinical setting, the system facilitates surgical planning for oral and maxillofacial procedures. It features real-time image acquisition, digital processing, and network-based image sharing. Clinicians use the reconstructed 3D/cross-sectional outputs to visualize anatomic structures, aiding in diagnostic support and surgical decision-making, potentially improving surgical outcomes through precise anatomical assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, design comparison, and software validation protocols.

Technological Characteristics

Computed tomography X-ray system; cone-beam geometry; CMOS-CT sensor with CsI + Photo Diode flat-panel detector; 12-bit grayscale; 0.2mm voxel size; 50-90 kVp range; 2-10 mA range; 0.4mm focal spot; 360-degree rotation; networked digital imaging; software-based reconstruction.

Indications for Use

Indicated for diagnostic support in oral and maxillofacial surgical planning. Patient population includes individuals requiring head and neck imaging, including ENT and dentomaxillofacial areas. Operated by physicians, dentists, and x-ray technicians.

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

• EPX-Impla (K070658)
• i-CAT Scanner (K061284)

Submission Summary (Full Text)

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## EXHIBIT 2 510(k) Summary

AUG 2 1 2008

E-Woo Technology Co., Ltd. 1F/4F/5F, Yunmin Technotown, 473-4, Bora-Dong, Giheung-Gu, Yongin-Si, Gyeonggi-Do, Korea 446-904 Tel: [phone] Fax: [phone] Taewoo Kim, President & CEO January 15, 2008

1. Identification of the Device:

Proprietary-Trade Name: "Picasso-Master also known as ECT and Master3D" Classification Name: System, X-Ray, Tomography, Computed / Product Code JAK Common/Usual Name: Computed Tomography X-ray System

2. Equivalent legally marketed device:

This product is similar in design and identical in function to E-Woo's computed tomography X-ray system Model EPX-Impla (K070658, E-Woo Technology Co., Ltd.), Extraoral Source X-ray System, Model i-CAT Scanner (K061284, Imaging Science International (nc.)

3. Indications for Use (intended use):

"Picasso-Master also known as ECT and Master3D" is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission from the same axial plane taken at different angles. It provides diagnostic details of the anatomics structures for surgical planning of oral and maxillofacial area by acquiring of the matomal image sequences lot the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray technicians.

#### 4. Description of the device:

"Picasso-Master also known as ECT and Master3D" is equipped with state-of-the-art CMOS-CT sensor to capture 3D x-ray computerized tomography scanned image. It is capable of real time-image acquisition through an advanced digital imaging process which allows considerably efficient diagnosis, information management, and real-time sharing of image information on network.

| Feature | Predicate:<br>(I-CAT Scanner, K061284) | Predicate: Dental Imaging<br>System<br>(EPX-Impla, K070658) | New Device<br>"Picasso-Master, ECT,<br>Master3D" |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Imaging Sciences International Inc.<br>USA | E-Woo Technology Co., Ltd.<br>Korea | E-Woo Technology Co., Ltd.<br>Korea |
| Intended Use | The Imaging Sciences International Inc. i-<br>CAT Scanner constructs a three<br>dimensional model from images taken<br>during a rotational X-ray sequence. The<br>Imaging Sciences i-CAT Scanner is<br>intended to be used whenever a dentist,<br>oral surgeon, or other physician needs 3D<br>information of high contrast objects.<br>The system is designed for imaging of | EPX-Impla is intended<br>to be used for three<br>Dimensional imaging for dental<br>Purposes. Provides details of<br>the anatomic structures for oral<br>and maxillofacial surgical<br>procedures. | "Picasso-Master, ECT,<br>Master3D" is a computed<br>tomography x-ray system<br>intended to produce<br>cross-sectional images of<br>the body by computer<br>reconstruction of x-ray<br>transmission data from |
| | | | |
| | TM Joint studies, mandible & maxilla for<br>implant planning, sinuses, and other areas<br>of the maxillofacial complex. | | the same axial plane<br>taken at different angles.<br>It provides diagnostic<br>details of the anatomic<br>structures for oral and<br>maxillofacial surgical<br>treatment. |
| Indication for<br>Use | The i-CAT Scanner is a dedicated X-Ray<br>imaging device that acquires a 360o<br>rotational X-ray sequence, reconstructs a<br>three-dimensional matrix of the examined<br>volume and produces two dimensional<br>views of this volume. The i-CAT Scanner<br>can measure distances and thickness on<br>two dimensional images.<br>Images produced by the i-CAT Scanner<br>can be printed or exported on magnetic<br>and optical media. | EPX-impla is a computed<br>tomography x-ray system that<br>acquires a 360° rotational<br>sequence of the head and neck<br>areas, including the ENT and<br>dentomaxillofacial area for use<br>in diagnostic support. The<br>device is operated and used by<br>physicians, dentists, and x-ray<br>technologists. | "Picasso-Master, AKA ECT,<br>Master3D"acquires a 360°<br>rotational sequence of the head<br>and neck areas, including the<br>ENT and dentomaxillofacial<br>area for use in diagnostic<br>support. The device is operated<br>and used by physicians,<br>dentists, and x-ray technicians. |
| X-ray Beam | Cone | Cone | Cone |
| Detector | Flat-Panel Detector<br>(Amorphous Silicon) | Flat-Panel Detector<br>(CsI + Photo Diode) | Flat-Panel Detector<br>(CsI + Photo Diode) |
| Grayscale | 14 | 12 | 12 |
| Voxel size (mm) | 0.2-0.4 | 0.2 | 0.2 |
| Number of<br>Voxel | 275 x 425 | 416 x 416 | 224 × 224 × 160 (20X15)<br>352 × 352 × 256 (20X15)<br>608 × 608 × 448 (20X15) |
| Rotation angle | 360 degree | 360 degree | 360 degree |
| Scan time (sec) | 10, 20 (standard), 40 | 15 | 24 |
| Pateint<br>position | Seated | Stand | Seated |
| FOV(3)<br>(cm x cm) | 17 x 13<br>16 x 22 (Optimal Extended FOV) | 12 x 7<br>8 x 5 | 20 x 15<br>20 x 19 |
| Reconstruction<br>time | 1.5min (20 sec scan) | Less than 2 min | 3min |
| KVp range | 120 | 40~90(Normal 85kV) | 50~90(Normal 85kV) |
| mA range | 3-8 (Pulse mode) | 2~10(Normal 7) | 2~10(Normal 7) |
| Focal spot<br>(mm) | 0.5 | 0.4 | 0.4 |
| CT Slice<br>Thickness | 0.800~0.200 mm | 0.1~1.0mm | 0.1~1.0mm |

#### 5. Safety and Effectiveness, comparison to predicate device

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#### 6. Testing information and Conclusion

In all material respects, the "Picasso-Master also known as ECT and Master3D" is substantially equivalent to Dental Imaging System EPX-Impla,(K070658, E-Woo Technology Co., Ltd.). 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.

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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 an eagle with its wings spread.

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: K081847

Trade/Device Name: Picasso-Master also known as ECT and Master 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 13, 2008 Received: August 14, 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.

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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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

Nancy C. Brogdon 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) :

Device Name : "Picasso-Master, also known as ECT and Master3D"

Indications For Use : "Picasso-Master also known as ECT and Master3D" is a computed tomography 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. It provides diagnostic details of the anatomic structures for surgical planning of oral and maxillofacial area by acquiring 360° rotational image sequences of the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray techniciana.

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)

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Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081847