CS 9600

K200183 · Trophy · OAS · Mar 13, 2020 · Radiology

Device Facts

• Record ID: K200183
• Device Name: CS 9600
• Applicant: Trophy
• Product Code: OAS · Radiology
• Decision Date: Mar 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

CS 9600 is an extraoral cone-beam computed tomography (CBCT) system. It captures data by rotating around the patient using a cone-shaped X-ray beam to reconstruct 2D or 3D images of dental, oral, maxillofacial, ENT, cervical spine, and wrist anatomy. An optional cephalometric modality uses a narrow-beam linear "slot technique" with a fan-shaped beam to scan the head in lines. Operated by healthcare professionals in clinical settings, the device provides diagnostic support for pediatric and adult patients. Features include low-dose mode, scout imaging, and optional metal artifact reduction (CS MAR) and 3D face scanning (CS Face Scan). Output is digital X-ray imagery used by clinicians for diagnostic assessment and growth/maturity evaluation. The device is designed for dental and maxillofacial diagnostic workflows.

Clinical Evidence

Bench testing only. Performance verified via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and imaging performance standards. Clinical images for the new cephalometric modality were acquired and reviewed by a qualified expert, confirming clinically acceptable diagnostic quality and effectiveness for the intended use.

Technological Characteristics

CBCT system; CMOS sensor technology; 16384 (14-bit) grayscale; 60-90 kV (optional 120 kV) tube voltage; 2-15 mA tube current; 0.3/0.7 mm focal spot. Connectivity via DICOM (NEMA PS 3.1-3.20). Software validated per IEC 62304. Cephalometric modality uses slot-scanning technique. Materials and components are consistent with predicate K181136.

Indications for Use

Indicated for pediatric and adult patients requiring 2D/3D digital X-ray imaging of dento-maxillofacial, ENT, cervical spine, and wrist regions for diagnostic support. Includes optional cephalometric imaging for hand/wrist carpus assessment for growth and maturity.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• CS 9600 (K181136)

Reference Devices

• CS 8100SC (K151087)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# ATTACHMENT 7

# INDICATIONS FOR USE STATEMENT

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## Indications for Use

510(k) Number (if known)

K200183

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) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(K) SUMMARY

K200183

### 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: [phone] 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: [phone] 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<br>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

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### 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.

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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<br>NAME<br>MODEL NAME | Trophy<br>CS 9600 | Trophy<br>CS 9600 |
| 510(K) Number | | K181136 |
| Indication for<br>use | CS 9600 is an extraoral system intended to produce<br>two-dimensional and three-dimensional digital X-ray<br>images of the dento-maxillofacial, ENT (Ear, Nose and<br>Throat), cervical spine and wrist regions at the direction<br>of healthcare professionals as diagnostic support for<br>pediatric and adult patients.<br>The CS 9600 can be upgraded to produce<br>cephalometric digital X-ray images. This includes<br>imaging the hand and wrist to obtain carpus image for<br>growth and maturity assessment. | CS 9600 is an extraoral system intended<br>to produce two-dimensional and three-<br>dimensional digital X-ray images of the<br>dento-maxillofacial, ENT (Ear, Nose and<br>Throat), cervical spine and wrist regions<br>at the direction of healthcare<br>professionals as diagnostic support for<br>pediatric and adult patients. |
| Performance<br>specification | · Panoramic modality<br>· 3D modality<br>· Cephalometric modality (optional) | · Panoramic modality<br>· 3D modality |
| Rated line<br>voltage | 100-240 Vac - 50/60 Hz | Same |
| X-ray tube<br>voltage | 60-90 kV<br>60-120 kV (in option) | Same |
| X-ray tube<br>current | 2-15 mA | Same |
| X-ray tube | DF-071G or OX/120-0307 | Same |
| Tube focal<br>spot | 0.3 or 0.7 mm | Same |
| Patient sizes | 4 patients sizes:<br>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<br>MODEL NAME | Proposed device<br>Trophy<br>CS 9600 | Primary Predicate device<br>Trophy<br>CS 9600 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | | K181136 |
| | Two-dimensional modality: PANORAMIC | |
| Sensor<br>technology | CMOS | Same |
| Image field | 6.4 x 140 mm (for adult patient size)<br>6.4 x 120 mm (for child patient size)<br>120 x 140 mm (for sinus one-shot exam) | Same |
| Gray scale | 16384 - 14 bits | Same |
| Magnification | 1.28 | Same |
| Radiological<br>Exams | • Full panoramic<br>• Segmented panoramic<br>• Bitewing<br>• Maxillary sinus<br>• Lateral TMJ x2 and Lateral TMJx4<br>• Sinus AP / PA / Lateral<br>• Orthogonal panoramic | Same |
| Exposure time | 0.5 to 13 seconds | Same |
| COMPANY NAME<br>MODEL NAME | Proposed device<br>Trophy<br>CS 9600 | Primary Predicate device<br>Trophy<br>CS 9600 |
| 510(K) Number | | K181136 |
| Three-dimensional modality: 3D | | |
| Sensor<br>technology | CMOS | Same |
| Field of View<br>(cm)<br>diameter x<br>height | • 4 x 4<br>• 5 x 5 (child 4 x 4)<br>• 5 x 8<br>• 6 x 6<br>• 8 x 5<br>• 8 x 8<br>• 10 x 5 (child 8 x 5)<br>• 10 x 10* (child 8 x 8) | • 12 x 5<br>• 12 x 10*<br>• 16 x 6<br>• 16 x 10*<br>• 16 x 12*<br>• 16 x 17*<br>* with tip of the volume<br>Same |
| Radiological<br>Exams | • Tooth/Teeth<br>• Jaw (full, upper or lower)<br>• Upper cervical spine | • TMJ<br>• Face<br>• ENT<br>• Wrist<br>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<br>Reduction | Yes in option (CS MAR) | Same |
| Concerned<br>anatomical sites | • Dento-maxillofacial area<br>• ENT area<br>• Cervical spine<br>• Hand/wrist | Same |
| Sensor model | CGF81 | Same |
| Sensor active<br>area (mm) | 120 x 140 | Same |
| Pixel size (µm) | 100 x 100 | Same |
| Sensor<br>resolution | 1200 x 1400 pixels | Same |
| Limiting<br>resolution | 5 lp/mm | Same |
| MTF, X-ray (%)<br>at 1 lp/mm,<br>Typical | 60 | Same |
| DQE, X-ray (%)<br>at 0 lp/mm,<br>Typical | 60 | Same |
| | Proposed device | Reference Device |
| COMPANY<br>NAME<br>MODEL NAME | Trophy<br>CS 9600 | Trophy<br>CS 8100SC |
| 510(K) Number | | K151087 |
| Indication for<br>use | CS 9600 is an extraoral system intended to<br>produce two-dimensional and three-dimensional<br>digital X-ray images of the dento-maxillofacial,<br>ENT (Ear, Nose and Throat), cervical spine and<br>wrist regions at the direction of healthcare<br>professionals as diagnostic support for pediatric<br>and adult patients.<br>The CS 9600 can be upgraded to produce<br>cephalometric digital X-ray images. This<br>includes imaging the hand and wrist to obtain<br>carpus image for growth and maturity<br>assessment. | The CS 8100SC and the CS 8100SC Access<br>are indicated to produce complete and<br>segmented tomographic digital panoramic and<br>cephalometric digital X-ray images<br>to be used at the direction of healthcare<br>professionals of the dento-maxillofacial region of<br>the human anatomy as diagnostic support for<br>pediatric and adult patients.<br>This includes imaging the hand and wrist to<br>obtain carpus image for growth and maturity<br>assessment.<br>In addition, the CS 8100SC is provided with the<br>panoramic radiological exam option which<br>allows the display of one determined segment of<br>the dental structures using<br>the capability of the system to explore each slide<br>during an exam. |
| Two-dimensional modality: CEPHALOMETRIC | | |
| Sensor<br>technology | CMOS | CMOS |
| Radiological<br>Exams | • Lateral<br>• Frontal AP or PA<br>• Oblique<br>• Submento-vertex<br>• Carpus (optional) | Same |
| Field of View<br>(cm) LxH | 18x18, 18x24 and 26x24 | Same |
| Gray scale | 16384 - 14 bits | Same |
| Exposure<br>time | 2.96 to 10 seconds | 3 to 10 seconds |
| Sensor model | CGC95 | Same |
| Sensor active<br>area (mm) | 131.6 x 6.4 | Same |
| Pixel size<br>(μm) | 100 x 100 | Same…