Not Found
No
The description focuses on standard digital X-ray imaging and reconstruction techniques, with no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.
No
This device is an imaging system used for diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used "for the diagnosis of the anatomical structure of the oral and maxillofacial area."
No
The device description explicitly lists multiple hardware components including an X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), and PC, in addition to 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 intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The described device is an X-ray imaging system. It uses X-rays to create images of the anatomical structure of the oral and maxillofacial area.
- Method of Operation: It works by irradiating the patient with X-rays and capturing the transmitted radiation to form an image. This is an in vivo process (within the living body), not an in vitro process (outside the living body using specimens).
- Intended Use: The intended use is for the diagnosis of anatomical structures based on imaging, not on the analysis of biological specimens.
Therefore, the T2 device, as described, falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
T2 is digital X-Ray imaging equipment for dental professionals that convert X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (Pano), Cephalometric (Ceph), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area.
Product codes
OAS
Device Description
T2 is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
oral and maxillofacial area, Maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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.
We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors.
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.
T2 complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2.
No clinical studies are submitted.
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
September 21, 2021
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION".
Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. FAIRLESS HILLS PA 19030
Re: K212303
Trade/Device Name: T2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS, Dated: July 20, 2021 Received: July 23, 2021
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,
Laurel M. Digitally signed by
Laurel M. Burk -S
Burk -S
Date: 2021.09.21
09:01:35 -04'00'
, 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) K212303
Device Name T2
Indications for Use (Describe)
T2 is digital X-Ray imaging equipment for dental professionals that convert X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (Pano), Cephalometric (Ceph), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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m Implant Co., Ltd ong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea 82 70 4626 0701 Fax: +82 70 4394 0404 www.osstem.com
K212303 - 510(k) Summary
Date: July 20, 2021
1. Company and Correspondent making the submission
| - Submitter's Name | : Osstem Implant Co., Ltd. |
|---|---|
| - Address | : 2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si |
| Gyeonggi-do, 15079, Republic of Korea | |
| - Contact | : Mr. Jinwoo Bae |
| - Phone | : +82-70-4626-0701 |
| - Correspondent's Name | : Hiossen Inc. |
| - Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact | : Mr. Peter Lee |
| - Phone | : +1-267-759-7031 |
2. Proposed Device
| Trade or (Proprietary) Name | : T2 |
|---|---|
| Classification Name | : X-Ray, Tomography, Computed, Dental |
| Regulation Number | : 21CFR892.1750 |
| Device Classification | : Class II |
| Classification Product Code | : OAS |
3. Predicated Device
Primary Predicate -T1-CS, T1-C, Osstem Implant Co., Ltd. (K183475)
4. Description
- T2 is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is
4
Image /page/4/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, lighter font. There is a small circle above the right side of the word "OSSTEM".
Osstem Implant Co., Ltd.
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea Tel: +82 70 4626 0701 Fax: +82 70 4394 0404 www.osstem.com
converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software
| Proposed Devices | Predicated Devices | Remark | ||
|---|---|---|---|---|
| Device Name | T2 | T1-CS, T1-C | Different | |
| 510(k) No. | Proposed | K183475 | Different | |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same | |
| Indications for Use | T2 is digital X-Ray imaging | |||
| equipment for dental | ||||
| professionals that convert X- | ||||
| Ray signals into digital | ||||
| signals to acquire 2D images | ||||
| and reconstruct them into 3D | ||||
| images, using Panoramic | ||||
| (Pano), Cephalometric | ||||
| (Ceph), and Computed | ||||
| Tomography (CT) | ||||
| technology for the diagnosis | ||||
| of the anatomical structure of | ||||
| the oral and maxillofacial | ||||
| area. | T1-C, T1-CS are 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 | ||||
| angleds. It provides | ||||
| diagnostic details of the | ||||
| anatomic structures by | ||||
| acquiring 360° rotational | ||||
| image sequences of oral and | ||||
| maxillofacial area from a | ||||
| precise treatment planningin | ||||
| adult and pediatric dentistry. | ||||
| The device is operated and | ||||
| used by physicians, dentists, | ||||
| and X-ray technicians. | Same | |||
| Perfomance Specification | Panoramic, cephalometric | |||
| and computed tomography | Panoramic, cephalometric | |||
| and computed tomography | Same | |||
| Input Voltage | 100-240VAC | 100-240 VAC | Same | |
| Tube Voltage | 60-95KV | 60-100 kV | Similar | |
| (included | ||||
| within | ||||
| range of | ||||
| predicated | ||||
| product) | ||||
| Tube Current | 5-11mA | 5-16 mA | Similar | |
| (included | ||||
| within | ||||
| range of | ||||
| predicated | ||||
| product) | ||||
| Focal Spot Size | 0.5mm | 0.5 mm | Same | |
| Exposure Time | Max. 22s | Max. 22 s | Same | |
| 2D Image Viewing Program | Model Name: 2D02 | Model Name: 2D01, 2D02 | Similar | |
| (included | ||||
| within | ||||
| predicated | ||||
| product) | ||||
| 3D Image Viewing Program | Model Name: 3D02 | Model Name: 3D01, 3D02 | Similar | |
| (included | ||||
| within | ||||
| predicated | ||||
| product) | ||||
| Anatomical Sites | Maxillofacial | Maxillofacial | Same | |
| Image | ||||
| Sensor | Computed | |||
| Tomography | 1515DXT | |||
| SEN1 | 1515DXT | |||
| SEN1 | Same | |||
| Panoramic | 1515DXT | |||
| SEN1 | 1515DXT | |||
| SEN1 | Same | |||
| Cephalometric | XID-C24DC | XID-C24DC | Same | |
| 1515DXT : Max. 15x9 | ||||
| SEN1 : Max 15x10 | ||||
| (Stiching Mode : Max 15 X 15) | 1515DXT : Max. 15x9 | |||
| SEN1 : Max 15x10 | Similar | |||
| (included | ||||
| within | ||||
| range of | ||||
| predicated | ||||
| product) | ||||
| Size of Imaging Volume | ||||
| (cm) | ||||
| Pixel | ||||
| Resolution | Computed | |||
| Tomography | 1515DXT : |
- 3.94 lp/mm
SEN1 : - 4.0 lp/mm | 1515DXT :
- 3.94 lp/mm
- 1.97 lp/mm
SEN1 : - 4.0 lp/mm
- 2.0 lp/mm | Same |
| | Panoramic | 1515DXT : 3.94 lp/mm
SEN1 : 4.0 lp/mm | 1515DXT : 3.94 lp/mm
SEN1 : 4.0 lp/mm | Same |
| | Cephalometric | XID-C24DC : 5 lp/mm | XID-C24DC : 5 lp/mm | Same |
| Pixel Size | Computed
Tomography | 1515DXT : - 127 μm * 127 μm
SEN1 : - 125 μm * 125 μm | 1515DXT :
- 127 μm * 127 μm
- 254 μm * 254 μm
SEN1 : - 125 μm * 125 μm
- 250 μm * 250 μm | Similar
(included
within
range of
predicated
product) |
| | Panoramic | 1515DXT : - 127 μm * 127 μm
SEN1 : - 125 μm * 125 μm | 1515DXT :
- 127 μm * 127 μm
SEN1 : - 125 μm * 125 μm | Same |
| | Cephalometric | XID-C24DC - 100 μm * 100 μm | XID-C24DC
- 100 μm * 100 μm | Same |
| | | | | |
| 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 | [CT]
- 1515DXT : 146 x 146 mm
- SEN1 : 160 x 128 mm
[Pano] - 1515DXT : 146 x 8.13 mm
- SEN1 : 160 x 8 mm | Same |
5. Substantial Equivalence Matrix
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Image /page/5/Picture/0 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font above the word "IMPLANT" in a smaller, lighter font. The logo is simple and modern.
Osstem Implant Co., Ltd.
OSSTERM IMPLANT CO., Ltd.
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Gibentg-si, Gyeonegi-do, 15079, Republic of Korea
Tel: +82 70 4626 0701 Fax: +82 70 4394 0404 www.osstem
6
Image /page/6/Picture/0 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, lighter font. The logo is simple and modern.
n Implant Co., Ltd
on-gil. Siheung-si. Gyeonggi-do. 15079. Republic of Korea Fax: +82 70 4394 0404 www.osstem.com
| [Ceph]
- 1.8 x 150 mm | [Ceph]
- 1.8 x 150 mm | |
|--------------------------|--------------------------|--|
|--------------------------|--------------------------|--|
6. Indications for Use
- T2 is digital X-Ray imaging equipment for dental professionals that converts X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (Pano), Cephalometric (Ceph), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area.
7. Summary of Non-clinical Performance Testing
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.
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
T2 complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2.
8. Summary of Clnical Testing
No clinical studies are submitted.
9. Conclusion
The indication for use and the technical characteristics of the subject device 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 size of image volume however, the non-clinical 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
7
Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.
Osstem Implant Co., Ltd.
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea
Tel: +82 70 4626 0701 Fax: +82 70 4394 0404 www.osstem.com
on the information provided in this submission, we conclude that the subject device is safe and effective and substantially equivalent to the predicate device.