(49 days)
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on the imaging modalities and features like low dose mode and metal artifact reduction.
No.
The device is strictly for diagnostic support by producing X-ray images, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to produce X-ray images "as diagnostic support." The "Device Description" section reiterates this.
No
The device description explicitly states that the CS 9600 is an "extraoral system" and a "cone-beam computed tomography (CBCT) x-ray system," which are hardware components. It also describes the physical process of rotation and capturing data using an x-ray beam.
Based on the provided information, the CS 9600 is not an In Vitro Diagnostic (IVD) device.
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. These tests are performed outside of the living body (in vitro).
- CS 9600 Function: The CS 9600 is an extraoral X-ray system that produces images of the patient's anatomy. It works by directing X-rays through the patient's body and capturing the resulting image data. This is an in vivo process (within the living body).
- Intended Use: The intended use is to produce digital X-ray images for diagnostic support. This involves imaging the patient directly, not analyzing samples taken from the patient.
Therefore, the CS 9600 falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CS 9600 is extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
Product codes
OAS
Device Description
CS 9600 is an extraoral system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
CS 9600 is a cone-beam computed tomography (CBCT) x-ray system. It means CS 9600 rotates around the patient, capturing data using a cone-shaped x-ray beam. These data are used to reconstruct a two or a three-dimensional (3D) image of the following regions of the patient's anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw and neck); ears, nose and throat region (ENT); cervical spine or wrist region.
Additional features such as low dose mode, scout image and metal artifact reduction are also provided by the CS 9600.
The CS 9600 can also be upgraded with cephalometric modality. The cephalometric modality of the proposed device CS 9600 is the same than the one available in the reference device K151087. The cephalometric mode works with a narrow beam linear scanning process called a "slot technique". The patient head is scanned in lines with a flat, fan-shaped x-ray beam.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions; hand and wrist
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare 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)
Performance Testing: Since there is no change on the two-dimensional panoramic and three-dimensional 3D modalities of the proposed device CS 9600 compared to the primary predicate device K181136, the performance testing was conducted on the new cephalometric modality added in the proposed device CS 9600. Following the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray imaging Devices, for the new cephalometric imaging applications, clinical images representative of the range of the different cephalometric radiological exams were taken. The cephalometric images were reviewed by a qualified expert and were evaluated to be of acceptable clinical effectiveness for the proposed indications for use. The CS 9600 set of images were deemed to be of a clinically usable diagnostic quality.
Non clinical and bench testing was conducted as part of design control to ensure the substantial equivalence of CS 9600 with the primary predicate device K181136 and reference device K151087. CS 9600 has been tested to ensure that the system as a whole operated in a safe and effective manner that is substantially equivalent to the primary predicate device and for the cephalometric modality to the predicate device. The results of the performance testing support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
March 13, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Trophy % Ms. Marie-Pierre Labat-Camy Global Regulatory Affairs Senior Manager 4 Rue F. Pelloutier - Croissy-Beaubourg 77435 Marne La Vallée, Cedex 2 FRANCE
Re: K200183
Trade/Device Name: CS 9600 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: January 22, 2020 Received: January 24, 2020
Dear Ms. Marie-Pierre Labat-Camy:
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 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-reporting
1
combination-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
ATTACHMENT 7
INDICATIONS FOR USE STATEMENT
3
Indications for Use
510(k) Number (if known)
Device Name
CS 9600
Indications for Use (Describe)
The CS 9600 is extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
| 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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4
510(K) SUMMARY
1. Date 510(k) Summary prepared
March 11, 2020
2. Submitter information
Applicant
Trophy 4 Rue F. Pelloutier - Croissy-Beaubourg 77435 Marne La Vallée, Cedex 2 France Phone: +33 1 64 80 85 26 Contact person: Ms. Marie-Pierre LABAT-CAMY
United Stated Sales Representative (U.S. Designated Agent):
Carestream Dental LLC 3625 Cumberland Boulevard, Suite 700, Atlanta. GA USA 30339 Phone: +1 (470) 481-4619 Contact: Mr. Sonny T. Nguyen
3. Device name and classification
Trade name: CS 9600 Regulation number: 21 CFR 892.1750 Requlation name (classification name): Computed tomography x-ray system Common name: Cone-beam computed tomography system Device Class: II Product Code: OAS
4. Predicate device and reference device
We consider the CS 9600 to be similar in design, composition and function to the following primary predicate device and reference device introduced into commercial distribution affer May 28, 1976:
| Primary
| Name | Predicate | Device | 510(k) | Company Name |
|---|---|---|---|---|
| CS 9600 | K181136 | Trophy |
Requlation number: 21 CFR 892.1750 Regulation name (classification name): Computed tomography x-ray system Common name: Cone-beam computed tomography system Device Class: II Product Code: OAS
| Reference Device Name | 510(k) | Company Name |
|---|---|---|
| CS 8100SC | K151087 | Trophy |
Regulation number: 21 CFR 872.1800 Regulation name (classification name): Extraoral source x-ray system Common name: X-ray imaging device Device Class: II Product Code: MUH
5
5. Device Description
CS 9600 is an extraoral system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
CS 9600 is a cone-beam computed tomography (CBCT) x-ray system. It means CS 9600 rotates around the patient, capturing data using a cone-shaped x-ray beam. These data are used to reconstruct a two or a three-dimensional (3D) image of the following regions of the patient's anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw and neck); ears, nose and throat region (ENT); cervical spine or wrist region.
Additional features such as low dose mode, scout image and metal artifact reduction are also provided by the CS 9600.
The CS 9600 can also be upgraded with cephalometric modality. The cephalometric modality of the proposed device CS 9600 is the same than the one available in the reference device K151087. The cephalometric mode works with a narrow beam linear scanning process called a "slot technique". The patient head is scanned in lines with a flat, fan-shaped x-ray beam.
6. Indication for use
CS 9600 is an extraoral system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
7. Substantial Equivalence
The subject device CS 9600, the primary predicate device K181136 and the reference device K151087 have the same intended use: extraoral x-ray systems that are intended to produce digital X-ray images at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
Both the CS 9600 and primary predicate device are intended as Cone-Beam Computed Tomography. The primary predicate device K181136 has the most similar indication for use and technological characteristics with the proposed device CS 9600.
6
The table below provides the summary of the technological characteristics of CS 9600 compared to the primary predicate device.
| Proposed device | Primary Predicate Device | |
|---|---|---|
| COMPANY | ||
| NAME | ||
| MODEL NAME | Trophy | |
| CS 9600 | Trophy | |
| CS 9600 | ||
| 510(K) Number | K181136 | |
| Indication for | ||
| use | CS 9600 is an extraoral system intended to produce | |
| two-dimensional and three-dimensional digital X-ray | ||
| images of the dento-maxillofacial, ENT (Ear, Nose and | ||
| Throat), cervical spine and wrist regions at the direction | ||
| of healthcare professionals as diagnostic support for | ||
| pediatric and adult patients. | ||
| The CS 9600 can be upgraded to produce | ||
| cephalometric digital X-ray images. This includes | ||
| imaging the hand and wrist to obtain carpus image for | ||
| growth and maturity assessment. | CS 9600 is an extraoral system intended | |
| to produce two-dimensional and three- | ||
| dimensional digital X-ray images of the | ||
| dento-maxillofacial, ENT (Ear, Nose and | ||
| Throat), cervical spine and wrist regions | ||
| at the direction of healthcare | ||
| professionals as diagnostic support for | ||
| pediatric and adult patients. | ||
| Performance | ||
| specification | · Panoramic modality | |
| · 3D modality | ||
| · Cephalometric modality (optional) | · Panoramic modality | |
| · 3D modality | ||
| Rated line | ||
| voltage | 100-240 Vac - 50/60 Hz | Same |
| X-ray tube | ||
| voltage | 60-90 kV | |
| 60-120 kV (in option) | Same | |
| X-ray tube | ||
| current | 2-15 mA | Same |
| X-ray tube | DF-071G or OX/120-0307 | Same |
| Tube focal | ||
| spot | 0.3 or 0.7 mm | Same |
| Patient sizes | 4 patients sizes: | |
| child, small adult, medium adult, large adult | Same |
The proposed CS 9600 and the primary predicate device CS 9600 (K181136) have the same panoramic two-dimensional modality and three-dimensional 3D modality.
| COMPANY NAME
MODEL NAME | Proposed device
Trophy
CS 9600 | Primary Predicate device
Trophy
CS 9600 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | | K181136 |
| | Two-dimensional modality: PANORAMIC | |
| Sensor
technology | CMOS | Same |
| Image field | 6.4 x 140 mm (for adult patient size)
6.4 x 120 mm (for child patient size)
120 x 140 mm (for sinus one-shot exam) | Same |
| Gray scale | 16384 - 14 bits | Same |
| Magnification | 1.28 | Same |
| Radiological
Exams | • Full panoramic
• Segmented panoramic
• Bitewing
• Maxillary sinus
• Lateral TMJ x2 and Lateral TMJx4
• Sinus AP / PA / Lateral
• Orthogonal panoramic | Same |
| Exposure time | 0.5 to 13 seconds | Same |
| COMPANY NAME
MODEL NAME | Proposed device
Trophy
CS 9600 | Primary Predicate device
Trophy
CS 9600 |
| 510(K) Number | | K181136 |
| Three-dimensional modality: 3D | | |
| Sensor
technology | CMOS | Same |
| Field of View
(cm)
diameter x
height | • 4 x 4
• 5 x 5 (child 4 x 4)
• 5 x 8
• 6 x 6
• 8 x 5
• 8 x 8
• 10 x 5 (child 8 x 5)
• 10 x 10* (child 8 x 8) | • 12 x 5
• 12 x 10*
• 16 x 6
• 16 x 10*
• 16 x 12*
• 16 x 17*
- with tip of the volume
Same |
| Radiological
Exams | • Tooth/Teeth
• Jaw (full, upper or lower)
• Upper cervical spine | • TMJ
• Face
• ENT
• Wrist
Same |
| Gray scale | 16384 - 14 bits | Same |
| Magnification | 1.4 | Same |
| Voxel size (µm) | 75, 150, 300 and 400 | Same |
| Exposure time | 3-20 seconds | Same |
| OTHER INFORMATION | | |
| Low dose mode | Yes | Same |
| Scout image | Yes | Same |
| 3D Face Photo | Yes in option (CS Face Scan) | Same |
| Metal Artefact
Reduction | Yes in option (CS MAR) | Same |
| Concerned
anatomical sites | • Dento-maxillofacial area
• ENT area
• Cervical spine
• Hand/wrist | Same |
| Sensor model | CGF81 | Same |
| Sensor active
area (mm) | 120 x 140 | Same |
| Pixel size (µm) | 100 x 100 | Same |
| Sensor
resolution | 1200 x 1400 pixels | Same |
| Limiting
resolution | 5 lp/mm | Same |
| MTF, X-ray (%)
at 1 lp/mm,
Typical | 60 | Same |
| DQE, X-ray (%)
at 0 lp/mm,
Typical | 60 | Same |
| | Proposed device | Reference Device |
| COMPANY
NAME
MODEL NAME | Trophy
CS 9600 | Trophy
CS 8100SC |
| 510(K) Number | | K151087 |
| Indication for
use | CS 9600 is an extraoral system intended to
produce two-dimensional and three-dimensional
digital X-ray images of the dento-maxillofacial,
ENT (Ear, Nose and Throat), cervical spine and
wrist regions at the direction of healthcare
professionals as diagnostic support for pediatric
and adult patients.
The CS 9600 can be upgraded to produce
cephalometric digital X-ray images. This
includes imaging the hand and wrist to obtain
carpus image for growth and maturity
assessment. | The CS 8100SC and the CS 8100SC Access
are indicated to produce complete and
segmented tomographic digital panoramic and
cephalometric digital X-ray images
to be used at the direction of healthcare
professionals of the dento-maxillofacial region of
the human anatomy as diagnostic support for
pediatric and adult patients.
This includes imaging the hand and wrist to
obtain carpus image for growth and maturity
assessment.
In addition, the CS 8100SC is provided with the
panoramic radiological exam option which
allows the display of one determined segment of
the dental structures using
the capability of the system to explore each slide
during an exam. |
| Two-dimensional modality: CEPHALOMETRIC | | |
| Sensor
technology | CMOS | CMOS |
| Radiological
Exams | • Lateral
• Frontal AP or PA
• Oblique
• Submento-vertex
• Carpus (optional) | Same |
| Field of View
(cm) LxH | 18x18, 18x24 and 26x24 | Same |
| Gray scale | 16384 - 14 bits | Same |
| Exposure
time | 2.96 to 10 seconds | 3 to 10 seconds |
| Sensor model | CGC95 | Same |
| Sensor active
area (mm) | 131.6 x 6.4 | Same |
| Pixel size
(μm) | 100 x 100 | Same |
| Sensor
resolution | 1316 x 64 pixels | Same |
| Limiting
resolution | 5 lp/mm | Same |
| MTF, X-ray
(%) at 1
lp/mm,
Typical | 60 | Same |
| DQE, X-ray
(%) at 0
lp/mm,
Typical | 60 | Same |
7
The proposed CS 9600 and the primary predicate device CS 9600 (K181136) have the same panoramic two-dimensional modality and three-dimensional 3D modality.
The main difference between the proposed CS 9600 and the primary predicate device K181136 is the difference in 2D imaging capabilities available with the addition in the proposed CS 9600 of the optional two-dimensional cephalometric modality.
The proposed device CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
8
When the CS 9600 is upgraded with cephalometric modality to produce cephalometric digital X-ray images, the cephalometric modality available is the same as the cephalometric modality available in previously cleared reference device K151087.
The following table provides the summary of the technological characteristics of the cephalometric modality of CS 9600 compared to the reference device K151087.
9
When the CS 9600 is upgraded with cephalometric modality to produce cephalometric digital X-ray images, the proposed CS 9600 and the reference device K151087 have the same cephalometric modality. Both systems are able to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
While the indication for use of primary predicate device K181136 and reference device K151087 are different, both devices have the same intended use, namely extraoral x-ray system.
The proposed device CS 9600 combines the indication for use of both the primary predicate device K181136 with the part of indication for use related to the cephalometric modality of the reference device K151087.
8. Non-Clinical Performance Data
The Testing to verify the performance requirements of the subject device CS 9600 was conducted and including in this premarket notification.
Standards Conformance:
EMC and Electrical Safety testing were performed respectively by LCIE and UL laboratory and found to meet all the requirements in standards IEC 60601-1: 2005 with A1 2012 (AAMI/ANSI ES60601-1:2005/R(2012), IEC 60601-1-2: 2014, IEC 60601-1-3: 2008 with A1 2013. IEC 60601-2-63: 2017 and IEC 62304: 2006 with A1 2015.
CS 9600 meets the provisions of NEMA PS 3.1-3.20. Digital Imaging and Communications in Medicine (DICOM) Set. The software contained in CS 9600 has been validated according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
The CS 9600 provides design features and instructions for pediation according to the FDA Guidance on Pediatric Information for X-ray Imaging Device Premarket Notifications.
Performance Testing:
Since there is no change on the two-dimensional panoramic and three-dimensional 3D modalities of the proposed device CS 9600 compared to the primary predicate device K181136, the performance testing was conducted on the new cephalometric modality added in the proposed device CS 9600. Following the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray imaging Devices, for the new cephalometric imaging applications, clinical images representative of the range of the different cephalometric radiological exams were taken. The cephalometric images were reviewed by a qualified expert and were evaluated to be of acceptable clinical effectiveness for the proposed indications for use. The CS 9600 set of images were deemed to be of a clinically usable diagnostic quality.
Non clinical and bench testing was conducted as part of design control to ensure the substantial equivalence of CS 9600 with the primary predicate device K181136 and reference device K151087. CS 9600 has been tested to ensure that the system as a whole operated in a safe and effective manner that is substantially equivalent to the primary predicate device and for the cephalometric modality to the predicate device. The results of the performance testing support substantial equivalence.
10
9. Conclusion
The comparison of characteristics supports substantial equivalence. CS 9600 is as safe and effective as the primary predicate device K181136 and as the reference device K151087 for the cephalometric modality.
CS 9600 is considered substantially equivalent to the primary predicate device K181136 because both have the most similar indication for use and technological characteristics. Both have the same panoramic two-dimensional modality and three-dimensional 3D modality. Cephalometric modality added in the proposed device CS 9600 is identical to the cephalometric modality included in previously cleared reference device K151087. The compared technical features for cephalometric imaging technology, Field of View, and other basic characteristics are matching very closely. There is no difference in the new cephalometric modality available in the proposed device CS 9600 and the cephalometric modality available on the reference device K151087. Therefore, the addition of the cephalometric modality to the CS 9600 does not raise questions of safety and effectiveness and does not have any effect on performance in practice.