NEWTOM VGI AND NEWTOM 5G

K130442 · Qr S.R.L. · OAS · Jul 3, 2013 · Radiology

Device Facts

• Record ID: K130442
• Device Name: NEWTOM VGI AND NEWTOM 5G
• Applicant: Qr S.R.L.
• Product Code: OAS · Radiology
• Decision Date: Jul 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

NewTom VGi is a cone beam computed tomography x-ray imaging system that acquires a 360 degree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires a 360 derree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. NewTom 5G is especially designed for: - dento-maxillo-facial complex imaging; - teeth, mandible and jaw imaging for implant planning; - temporal-mandibular joint (TMJ) imaging; - ear, nose and throat (ENT) analysis; - sections of upper cervical-spine imaging;

Device Story

Cone beam computed tomography (CBCT) system; acquires 360-degree rotational X-ray sequences of head/neck region. Transforms raw projection data into 3D volumetric matrix; generates 2D and 3D diagnostic views. Operated by physicians, dentists, and technologists in clinical settings. Output used for diagnostic support and implant planning; assists clinicians in visualizing anatomical structures of skull, jaw, and cervical spine. Benefits include high-resolution volumetric imaging for precise surgical/treatment planning.

Clinical Evidence

No clinical data provided; device relies on bench testing and technological equivalence to existing CBCT systems.

Technological Characteristics

Cone beam computed tomography (CBCT) X-ray system; 360-degree rotational acquisition; 3D volumetric reconstruction; 2D/3D image display; Class II device (OAS).

Indications for Use

Indicated for diagnostic imaging of the head, including ENT, dento-maxillofacial complex, TMJ, human skull, neck, and upper cervical spine. Used by physicians, dentists, and x-ray technologists for diagnostic support and implant planning.

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 Hamoshire Avenue Document Control Center - WO66-GBOS Silver Spring, MD 20993-0002

July 3, 2013

OR s.r.l. % Mr. Claude Berthoin President Thelma USA 110 E. Granada Blvd., Suite 209 ORMOND BEACH FL 32176

Re: K130442

Trade/Device Name: NewTom VGi and NewTom 5G Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: June 5. 2013 Received: June 7, 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 (IPMA). 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 device-related adverse events) (21 CFR 803): good manufacturing practive 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.

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Page 2 - Mr. Berthoin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or (301) 796-7.100 or at its Internet address

http://www.fda.20v/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.lda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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,

Jaming M. Mense

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

510(k) Number (if known): K130442

NewTom VGi

Indications for Use:

Device Name:

NewTom VGi is a cone beam computed tomography x-ray imaging system that acquires a 360 degree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals

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)

Raming M. Menge

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

K130442 210(k)

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## Indications for Use

K130442 510(k) Number (if known):

Device Name: NewTom 5G

Indications for Use:

NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires a 360 derree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

NewTom 5G is especially designed for:

- dento-maxillo-facial complex imaging;
- teeth, mandible and jaw imaging for implant planning;
- temporal-mandibular joint (TMJ) imaging;
- ear, nose and throat (ENT) analysis;
- sections of upper cervical-spine imaging;

イ 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)

Jamingh. M. Morge

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

K130442 510(k)

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