(256 days)
Not Found
No
The summary describes a standard dental X-ray system with different imaging modes and computer reconstruction of X-ray data. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The "computer reconstruction" mentioned is a standard technique in CT imaging and does not inherently imply AI/ML.
No.
The device is an imaging system designed to produce diagnostic images for treatment planning, not to directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "provides diagnostic details of the anatomic structures" and "acquires 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning." The "Device Description" also mentions that the CT detector is used to "capture radiographic diagnostic images of oral anatomy." These statements clearly indicate its use in diagnosing.
No
The device description explicitly states it is a "complete dental X-ray system equipped with X-ray tube, generator and dedicated detector," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the T1-C, T1-CS is a computed tomography x-ray system that produces images of the oral anatomy. It uses X-rays to create images, not to analyze biological samples.
- Intended Use: The intended use is for diagnostic imaging of the oral and maxillofacial area for treatment planning. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro.
The device is a medical imaging device, specifically a dental radiographic imaging system, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crossectional images of the oral anatomy on a real time basis by computer reconstruction of X-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and X-ray technicians.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
"T1-C, T1-CS", a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, "T1-C, T1-CS" are a complete dental X-ray system equipped with X-ray tube, generator and dedicated detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on digital X-ray detector. CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental X-ray system based on X-ray detector. T1-CS provides three modes, Whereas, T1-C provides only panoramic and cone beam computed tomography mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
oral anatomy, oral and maxillofacial area
Indicated Patient Age Range
adult and pediatric dentistry
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)
Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device.
Non-Clinical Performance Data: We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors.
Clinical Performance Data: A clinical study was completed to evaluate the image quality of T1-C, T1-CS's maxillofacial area. The clinical images of patients are presented as the clinical data including date and signature by a licensed professional. The images acquired using T1-C. T1-CS were reviewed by qualified clinicians to be of acceptable clinical effectiveness for the proposed indications for use. The results show that the imaging position, which is different from the one in the predicate device, gives a clinically sufficient image quality.
Software Verification and Validation Testing: Software was designed and developed according to a software development process. Also, Software verification and validation test were conducted and documented in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005. The software for this device contains "Moderate" level of concern software.
Safety, EMC and Performance Data: T1-C, T1-CS complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2.
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
August 30, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Osstem Implant Co., Ltd. % Peter Lee Official Correspondent Hiossen Inc. 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K183475
Trade/Device Name: T1-C. T1-CS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: December 13, 2018 Received: December 17, 2018
Dear Peter 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K183475
Device Name T1-C, T1-CS
Indications for Use (Describe)
T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crossectional images of the oral anatomy on a real time basis by computer reconstruction of X-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and X-ray technicians.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Image /page/3/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray underneath. There is a small orange swirl design to the right of the word "OSSTEM".
510(k) Summary
(K183475)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date : 7/31/2019
2. Submitter / Correspondent
| Submitter: | OSSTEM IMPLANT Co., Ltd. | ||
|---|---|---|---|
| 2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, | |||
| Gyeonggi-do, 15079, Republic of Korea | |||
| Contact: Jiyoon Ha | |||
| Tel.: +82 70 4394 7809 |
| Correspondent's Name: | HIOSSEN Inc. |
|---|---|
| 85 Ben Fairless Drive, Fairless Hills, PA 19030 | |
| Contact: Peter Lee | |
| Tel.: 267-759-7031 |
3. Trade/Proprietary Name:
T1-C. T1-CS
4. Common Name:
Computed tomography x-rav system
5. Classification:
21 CFR 892.1750, Class II Classification Name: Computed tomography X-ray system Product Code, OAS
6. Device Description:
"T1-C, T1-CS", a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, "T1-C, T1-CS" are a complete dental X-ray system equipped with X-ray tube, generator and dedicated detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on digital X-ray detector. CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental X-ray system based on X-ray detector. T1-CS provides three modes, Whereas, T1-C provides only panoramic and cone beam computed tomography mode.
SYSTEM's Key Components:
- · SSXI detectors (1515DXT, SEN1, XID-C24DC)
- · PC system
- CPU: Intel i5-4590 3.0GHz
- RAM: > 8GB
- Hard disk drive: 256GB (SSD recommended)
- Graphic board: Nvidia GeForce GTX970
- Hard disk space: 256GB
- · Imaging Software
- 2D Viewer : Xvision (Model Name : 2D-001), One vision (Model Name : 2D-002)
- 3D Viewer : OneClinic (Model Name : 3D-001), One 3D (Model Name : 3D-002)
4
Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the letters connected in a stylized font. Below "OSSTEM", the word "IMPLANT" is written in gray, in a smaller, sans-serif font. The logo is simple and modern, with a focus on the brand name.
7. Indication for use:
T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crossectional images of the oral anatomy on a real time basis by computer reconstruction of X-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and X-ray technicians.
8. Predicate Device:
Manufacturer: Vatech Co., Ltd Device Name: PHT-30LFO (Pax-i3D Smart) Regulation Name: Computed Tomography X-ray System Classification No.: 21CFR 892.1750, Class II Product Code: OAS 510(k) Number: K152106
9. Substantial Equivalence:
"T1-CS, T1-C" described in this 510(k) has the similar intended use and technical characteristics as the PHT-30LFO of Vatech Co., Ltd.
Although the detector sizes of our device and the predicate device are different, this difference does not affect the substantially equivalent performance of our device to the predicate, and it does not affect the scope of intended use compared to the predicate device.
| Characteristic | Subject Device
OSSTEM IMPLANT Co., Ltd.
T1-CS, T1-C | Predicate Device
Vatech Co., Ltd.
PHT-30LFO (PaX-i3D Smart) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K183475 | K152106 |
| Indications for Use | T1-C, T1-CS are a computed
tomography x-ray system intended
to produce panoramic,
cephalometric or crosssectional
images of the oral anatomy on a
real time basis by computer
reconstruction of X-ray image data
from the same axial plane taken at
different angles. It provides
diagnostic details of the anatomic
structures by acquiring 360°
rotational image sequences of oral
and maxillofacial area for a precise
treatment planning in adult and
pediatric dentistry. The device is
operated and used by physicians,
dentists, and X-ray technicians.
T1-CS provides three modes,
whereas, T1-C provides only
panoramic and cone beam
computed tomography mode. | PHT-30LFO is a computed
tomography x-ray system intended
to produce panoramic,
cephalometric or crosssectional
images of the oral anatomy on a
real time basis by computer
reconstruction of X-ray image data
from the same axial plane taken at
different angles. It provides
diagnostic details of the anatomic
structures by acquiring 360°
rotational image sequences of oral
and maxillofacial area for a precise
treatment planning in adult and
pediatric dentistry. The device is
operated and used by physicians,
dentists, and X-ray technicians. |
| Performance Specification | Panoramic, cephalometric
and | Panoramic,
cephalometric
and |
| | computed tomography | computed tomography |
| Input Voltage | AC 100-240 V | AC 100-240 V |
| Tube Voltage | 60-100 kV | 50-99 kV |
| Tube Current | 516 mA | 416 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | Max. 22 s | Max. 18 s |
| Slice Width | 0.2-1.0mm | 0.1 mm min |
5
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea
Image /page/5/Picture/2 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
| Chin Rest | Equipped Headrest | Equipped Headrest | |
|---|---|---|---|
| Mechanical | Compact design | Compact design | |
| 2D Image Viewing Program | Model Name: 2D01, 2D02 | EasyDent | |
| 3D Image Viewing Program | Model Name: 3D01, 3D02 | Ez3D Plus | |
| Anatomical Sites | Maxillofacial | Maxillofacial | |
| Image | |||
| Receptor | Computed | ||
| Tomography | 1515DXT | ||
| SEN1 | Xmaru1404CF | ||
| Panoramic | 1515DXT | ||
| SEN1 | Xmaru1404CF | ||
| Cephalometric | XID-C24DC | Xmaru2301CF | |
| 1210SGA | |||
| 910SGA | |||
| Xmaru2301CF-O | |||
| Size of Imaging Volume | |||
| (cm) | 1515DXT : Max. 15x9 | ||
| SEN1 : Max 15x10 | Xmaru1404CF : Max. 10x8.5 | ||
| Pixel | |||
| Resolution | Computed | ||
| Tomography | 1515DXT : |
- 3.94 lp/mm -1x1 binning
- 1.97 lp/mm - 2x2 binning
SEN1 : - 4.0 lp/mm - 1x1 binning
- 2.0 lp/mm - 2x2 binning | Xmaru1404CF :
- 5.0 lp/mm - 2x2 binning
- 2.5 lp/mm - 4x4 binning |
| | Panoramic | 1515DXT : 3.94 lp/mm
SEN1 : 4.0 lp/mm | Xmaru1404CF : - 5.0 lp/mm - 2x2 binning
- 2.5 lp/mm - 4x4 binning |
| | Cephalometric | XID-C24DC : 5 lp/mm | Xmaru2301CF : 5 lp/mm
1210SGA : 3.9 lp/mm
910SGA : 3.9 lp/mm
Xmaru2301CF-O : 5 lp/mm |
| Pixel Size | Computed
Tomography | 1515DXT : - 127 $μm$ - 1x1 binning
- 254 $μm$ - 2x2 binning
SEN1 : - 125 $μm$ - 1x1 binning
- 250 $μm$ - 2x2 binning | Xmaru1404CF :
- 99 $μm$ - 2x2 binning
- 198 $μm$ - 4x4 binning |
| | Panoramic | 1515DXT: 127 $μm$
SEN1: 125 $μm$ | Xmaru1404CF : - 99 $μm$ - 2x2 binning
- 198 $μm$ - 4x4 binning |
| | Cephalometric | XID-C24DC: 100 $μm$ | Xmaru2301CF : 100 x 100 $μm$
1210SGA : 127 x 127 $μm$
910SGA : 127 x 127 $μm$
Xmaru2301CF-O : 100 x 100 |
| Active Area | | [CT]
· 1515DXT : 146 x 146 mm
· SEN1 : 160 x 128 mm
[Pano]
· 1515DXT : 146 x 8.13 mm
· SEN1 : 160 x 8 mm
[Ceph] | [CT]
· Xmaru1404CF : 135.8 x 36.4 mm
[Pano]
· Xmaru1404CF : 135.8 x 5.94 mm
[Ceph]
· Xmaru2301CF : 5.9 x 230.4 mm
· 1210SGA : 260.1 x 325.1 mm |
10. Performance Data:
Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device.
6
Image /page/6/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small orange circle above the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
Non-Clinical Performance Data
We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors.
Clinical Performance Data
A clinical study was completed to evaluate the image quality of T1-C, T1-CS's maxillofacial area. The clinical images of patients are presented as the clinical data including date and signature by a licensed professional. The images acquired using T1-C. T1-CS were reviewed by qualified clinicians to be of acceptable clinical effectiveness for the proposed indications for use. The results show that the imaging position, which is different from the one in the predicate device, gives a clinically sufficient image quality.
Software Verification and Validation Testing
Software was designed and developed according to a software development process. Also, Software verification and validation test were conducted and documented in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005. The software for this device contains "Moderate" level of concern software.
Safety, EMC and Performance Data
T1-C, T1-CS complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2.
- A IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 Medical electrical equipment - General requirements for basic safety and essential performance
-
IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Usability
-
IEC 60601-1-3:2008 (Second Edition) + A1:2013 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X ray equipment
-
IEC 60601-2-63:2012 (First Edition) Medical electrical equipment - Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
-
IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
IEC62366:2007 (First Edition) + A1: 2014 Medical devices – Application of usability engineering to medical devices
- A Non-Clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Device"
-
Testing to confirm compliance with Acceptance Tests
11. Conclusion:
The indication for use and the technical characteristics of the is substantially equivalent to the predicate device. It is substantially equivalent to predicate device in output characteristics and operation mode (CT, Cephalo, Panorama). The major difference is active area size, however, the nonclinical and clinical study results show that the subject device is substantially equivalent to the predicate device. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and Based on the information provided in this submission, we conclude that the subject device is safe and effective and substantially equivalent to the predicate device.