(52 days)
Not Found
No
The description mentions "advanced digital imaging process" and "computer reconstruction," which are standard techniques in CT imaging and do not necessarily imply AI/ML. There is no mention of AI, ML, deep learning, or any related terms in the provided text. The performance study and key metrics sections are also "Not Found," which would typically be present if AI/ML was a core component requiring specific validation.
No
The device is described as an x-ray system intended to produce images for diagnostic purposes and surgical planning, not for treating a disease or condition.
Yes
The "Picasso-Master" is described as providing "diagnostic details of the anatomic structures" and allowing for "considerably efficient diagnosis," directly indicating its role in the diagnostic process.
No
The device description explicitly states it is a "computed tomography x-ray system" equipped with a "CMOS-CT sensor," which are hardware components. While it includes software for image processing and reconstruction, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a computed tomography x-ray system that produces images of the body itself. It uses x-rays to create cross-sectional images, not to analyze biological samples.
The intended use clearly describes the device's function as an imaging system for surgical planning and providing diagnostic details of anatomical structures. This aligns with the definition of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
JAK
Device Description
"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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
oral and maxillofacial area, head and neck areas, including the ENT and dentomaxillofacial area.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, dentists, and x-ray 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
§ 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
Korisy7?
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: 82-31-899-7967 Fax: 82-31-286-3007 Taewoo Kim, President & CEO January 15, 2008
- 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
- 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.)
- 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:
(I-CAT Scanner, K061284) | Predicate: Dental Imaging
System
(EPX-Impla, K070658) | New Device
"Picasso-Master, ECT,
Master3D" |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Imaging Sciences International Inc.
USA | E-Woo Technology Co., Ltd.
Korea | E-Woo Technology Co., Ltd.
Korea |
| Intended Use | The Imaging Sciences International Inc. i-
CAT Scanner constructs a three
dimensional model from images taken
during a rotational X-ray sequence. The
Imaging Sciences i-CAT Scanner is
intended to be used whenever a dentist,
oral surgeon, or other physician needs 3D
information of high contrast objects.
The system is designed for imaging of | EPX-Impla is intended
to be used for three
Dimensional imaging for dental
Purposes. Provides details of
the anatomic structures for oral
and maxillofacial surgical
procedures. | "Picasso-Master, ECT,
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 |
| | | | |
| | TM Joint studies, mandible & maxilla for
implant planning, sinuses, and other areas
of the maxillofacial complex. | | the same axial plane
taken at different angles.
It provides diagnostic
details of the anatomic
structures for oral and
maxillofacial surgical
treatment. |
| Indication for
Use | The i-CAT Scanner is a dedicated X-Ray
imaging device that acquires a 360o
rotational X-ray sequence, reconstructs a
three-dimensional matrix of the examined
volume and produces two dimensional
views of this volume. The i-CAT Scanner
can measure distances and thickness on
two dimensional images.
Images produced by the i-CAT Scanner
can be printed or exported on magnetic
and optical media. | EPX-impla is a computed
tomography x-ray system that
acquires a 360° rotational
sequence of the head and neck
areas, including the ENT and
dentomaxillofacial area for use
in diagnostic support. The
device is operated and used by
physicians, dentists, and x-ray
technologists. | "Picasso-Master, AKA ECT,
Master3D"acquires a 360°
rotational sequence of the head
and neck areas, including the
ENT and dentomaxillofacial
area for use in diagnostic
support. The device is operated
and used by physicians,
dentists, and x-ray technicians. |
| X-ray Beam | Cone | Cone | Cone |
| Detector | Flat-Panel Detector
(Amorphous Silicon) | Flat-Panel Detector
(CsI + Photo Diode) | Flat-Panel Detector
(CsI + Photo Diode) |
| Grayscale | 14 | 12 | 12 |
| Voxel size (mm) | 0.2-0.4 | 0.2 | 0.2 |
| Number of
Voxel | 275 x 425 | 416 x 416 | 224 × 224 × 160 (20X15)
352 × 352 × 256 (20X15)
608 × 608 × 448 (20X15) |
| Rotation angle | 360 degree | 360 degree | 360 degree |
| Scan time (sec) | 10, 20 (standard), 40 | 15 | 24 |
| Pateint
position | Seated | Stand | Seated |
| FOV(3)
(cm x cm) | 17 x 13
16 x 22 (Optimal Extended FOV) | 12 x 7
8 x 5 | 20 x 15
20 x 19 |
| Reconstruction
time | 1.5min (20 sec scan) | Less than 2 min | 3min |
| KVp range | 120 | 4090(Normal 85kV) | 5090(Normal 85kV) |
| mA range | 3-8 (Pulse mode) | 210(Normal 7) | 210(Normal 7) |
| Focal spot
(mm) | 0.5 | 0.4 | 0.4 |
| CT Slice
Thickness | 0.8000.200 mm | 0.11.0mm | 0.1~1.0mm |
5. Safety and Effectiveness, comparison to predicate device
1
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.
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 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.
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 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 .
4
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)
Page 1 of 1
_
(Division Sign-Off)_
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081847