(166 days)
Not Found
Not Found, Not Found
No
The summary describes standard image reconstruction and display techniques for a CT system and does not mention AI or ML.
No
The device is described as an "x-ray imaging system" used "for use in diagnostic support," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for use in diagnostic support."
No
The device description explicitly states it is a "cone beam computed tomography x-ray imaging system," which is a hardware-based imaging modality. The software component is for image reconstruction and display, but it is part of a larger hardware system.
Based on the provided information, the NewTom 5G is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- NewTom 5G Function: The description clearly states that the NewTom 5G is an x-ray imaging system that acquires images of anatomical structures within the human body (head, neck, lower extremities). It does not analyze specimens taken from the body.
The device is a medical imaging device used for diagnostic support based on visualizing internal anatomy, which is distinct from the function of an IVD.
N/A
Intended Use / Indications for Use
The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities 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.
Product codes
OAS, JAK
Device Description
The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities 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.
Mentions image processing
reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone beam computed tomography x-ray imaging
Anatomical Site
head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
QR S.r.l. % Mrs. Marisa Testa President/CEO THEMA S.r.1. Via G. Saragat N.5 Imola, Bo 40026 ITALY
Re: K142222
Trade/Device Name: NewTom 5G Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS, JAK Dated: December 22, 2014 Received: December 29, 2014
Dear Mrs. Testa:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142222
Device Name NewTom 5G
Indications for Use (Describe)
The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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