CLARISCT

K120753 · Icrco, Inc. · OAS · Jul 26, 2012 · Radiology

Device Facts

• Record ID: K120753
• Device Name: CLARISCT
• Applicant: Icrco, Inc.
• Product Code: OAS · Radiology
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The Claris CBCT accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both twodimensional images and three-dimensional renderings ...

Device Story

Claris CBCT is a dedicated X-ray imaging system for dento-maxillo-facial applications. Device acquires 360-degree rotational X-ray image sequences; reconstructs 3D volumetric matrix from acquired data. System produces 2D views and 3D renderings for clinical display. Used in clinical settings by trained professionals (radiologists, surgeons, dentists) to support diagnostic decision-making in radiology and maxillofacial surgery. Visual output allows clinicians to assess anatomical structures, aiding surgical planning and diagnostic evaluation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Computed tomography X-ray system; 360-degree rotational acquisition; 3D volumetric reconstruction; 2D and 3D image display. Class II device (21 CFR 892.1750).

Indications for Use

Indicated for diagnostic imaging support of the dento-maxillo-facial complex and maxillofacial surgery in patients requiring dental or maxillofacial radiographic 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)

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## 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

JUL 2 6 2012

Mr. Greg Wachtler Manager, Regulatory Compliance ICRco Inc. 2580 W. 237th Street TORRANCE CA 90505

Re: K120753

Trade/Device Name: Claris CBCT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 25, 2012 Received: June 5, 2012

#### Dear Mr. Wachtler:

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 10 more word in 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 r ou mayy and controls 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 that I Drives intatutes and regulations administered by other Federal agencies. You must or arry 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

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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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known): K120753

Device Name: Claris CBCT

Indications for Use: The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.

The Claris CBCT accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both twodimensional images and three-dimensional renderings ...

Prescription Use: YES

ANDIOR

Over-the-Counter Use: NO

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Radiological Device Office of in Vitrg 610K

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