CS 9300, CS 9300C

K103659 · Trophy · OAS · Aug 18, 2011 · Radiology

Device Facts

• Record ID: K103659
• Device Name: CS 9300, CS 9300C
• Applicant: Trophy
• Product Code: OAS · Radiology
• Decision Date: Aug 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CS 9300 and CS 9300C are systems intended to produce two-dimensional and three-dimensional digital x-ray images of the dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. In addition, the CS 9300C is intended to produce cephalometric images. This includes imaging the hand and wrist to obtain the carpus image for growth and maturity assessment.

Device Story

CS 9300 and CS 9300C are computed tomography X-ray systems; produce 2D and 3D digital images of dento-maxillo-facial and ENT regions. CS 9300C includes cephalometric imaging capability for hand/wrist carpus assessment. Operated by healthcare professionals in clinical settings; provides diagnostic support for pediatric and adult patients. System captures X-ray projections; reconstructs images for clinician review. Output aids in anatomical assessment and clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and technological comparison.

Technological Characteristics

Computed tomography X-ray system; 2D/3D digital imaging; cephalometric imaging (CS 9300C); dento-maxillo-facial and ENT application; Class II device.

Indications for Use

Indicated for pediatric and adult patients requiring 2D/3D digital X-ray imaging of dento-maxillo-facial and ENT regions. CS 9300C additionally indicated for cephalometric imaging, including hand/wrist carpus imaging for growth/maturity assessment.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Marie-Pierre Labat-Camy Regulatory Affairs Manager Trophy 4, rue F. Pelloutier-Croissy-Beaubourg 77435 Marne La Vallée Cedex 2 FRANCE

AUG 1 8 2011

Re: K103659 Trade/Device Name: CS 9300 and CS 9300C Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: August 15, 2011 Received: August 16, 2011

Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{1}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Traditional 510(k): CS 9300 and CS 9300C

## INDICATIONS FOR USE

### 510 (k) Number: K103659

CS 9300 and CS 9300C Device Name:

### Indications For Use:

The CS 9300 and CS 9300C are systems intended to produce two-dimensional and three-dimensional digital x-ray images of the dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

In addition, the CS 9300C is intended to produce cephalometric images. This includes imaging the hand and wrist to obtain the carpus image for growth and maturity assessment.

Prescription Use X (21 CFR 801 Subpart D )

and/or

Over-The-Counter Use ( 21 CFR 801 Subpart C )

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K

6163659