HYPERION X9

K123381 · Cefla S.C. · OAS · May 10, 2013 · Radiology

Device Facts

• Record ID: K123381
• Device Name: HYPERION X9
• Applicant: Cefla S.C.
• Product Code: OAS · Radiology
• Decision Date: May 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

Hyperion X9 is a digital panoramic, cephalometric and tomographic extra-oral X-ray system. indicated for use in: (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH); (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition (teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option. The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings. This technique is known as CBCT or CB3D.

Device Story

Hyperion X9 is a digital extra-oral X-ray system for dental and maxillofacial imaging. It captures panoramic, cephalometric, and tomographic (CBCT) images. For CBCT, the device performs a 360-degree rotational X-ray sequence to acquire raw data, which is then reconstructed into a 3D matrix. The system outputs 2D images and 3D renderings for clinical review. Used in dental clinics and diagnostic imaging centers; operated by trained dental professionals or radiologic technicians. The output assists clinicians in diagnosing conditions related to teeth, jaws, oral structures, and cranial bones. The device provides high-resolution visualization of anatomical structures to support treatment planning and diagnostic decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing.

Technological Characteristics

Digital extra-oral X-ray system; 360-degree rotational X-ray source; CBCT reconstruction capability; produces 2D and 3D volumetric data; intended for maxillofacial imaging; class II device under 21 CFR 892.1750.

Indications for Use

Indicated for patients requiring diagnostic imaging of the maxillofacial area, dentition, jaws, oral structures, skull, and carpus. Used for panoramic, cephalometric, and tomographic (CBCT) examinations.

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)

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

May 10, 2013

Cefla S.C. % Mr. Claude Berthoin President Thema USA 110 E. Granada Blvd. Suite 207 ORMOND BEACH FL 32176

Re: K123381

Trade/Device Name: Hyperion X9 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS, MUH Dated: April 08, 2013 Received: April 09, 2013

Dear Mr. Berthoin:

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. 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 (reporting of medical

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Page 2 - Mr. Berthoin

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sm.h.7)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K123381 510(k) Number (if known):

Device Name: Hyperion X9

Indications for Use:

Hyperion X9 is a digital panoramic, cephalometric and tomographic extra-oral X-ray system. indicated for use in:

- (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and
- (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH);
- (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition (teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option.

The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings. This technique is known as CBCT or CB3D.

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K123381 510(k) ==

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