(27 days)
Not Found
No
The summary describes standard image reconstruction techniques for CT imaging and does not mention AI or ML.
No
The device is used for diagnostic imaging (acquiring X-ray images and reconstructing 3D models) to support diagnosis in radiology and maxillofacial surgery, rather than for treating or mitigating a disease or condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "for use as diagnostic support in radiology."
No
The device description explicitly states that the NewTom VG includes hardware components such as a scanner unit (X-ray source, flat panel detector, motorized arm) and a control box, in addition to the software.
Based on the provided information, the NewTom VG Computed Tomography X-ray System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- NewTom VG Function: The NewTom VG is an X-ray imaging device. It acquires images of the dento-maxillo-facial complex within the patient's body using X-rays. It does not analyze biological specimens.
The device's function is clearly described as an imaging system for diagnostic support in radiology and maxillofacial surgery, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The NewTom VG Computed Tomography X-ray System is a dedicated X-ray 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 NewTom VG accomplishes this task by 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.
Product codes
MUH
Device Description
The NewTom VG Computed Tomography X-Ray System (NewTom VG) is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images. It then reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of such volume, displaying both two- and three-dimensional images. The NewTom VG can measure distances and thickness on two-dimensional images. Such images can be printed or exported on magnetic and optical media.
The NewTom VG is designed for use in diagnostic support both in dento-maxillofacial radiology, with a particular reference to "planning" and to monitoring of implantations, and in the field of maxillofacial surgery.
The NewTom VG hardware, including a scanner unit (comprised of an X-ray source, flat panel detector and a motorized arm) and a control box. facilitates the acquisition of a full X-ray sequence by the device software. The NewTom VG software runs on an x86 architecture based workstation. The NewTom VG reconstructs a three-dimensional model of x-ray images similar to the threedimensional model obtained using the parent NewTom 3G Computed Tomography X-Ray System (NewTom 3G).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
dento-maxillo-facial complex, maxillofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety, EMC/EMI testing, and verification and validation testing were performed to support the hardware and software modifications. The NewTom VG Computed Tomography X-Ray System met all requirements, and functioned as intended and is therefore safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
SEP | 8 2007
Special 510(k) Summary for NewTom VG Computed Tomography X-Ray System
1. SPONSOR
AFP Imaging Corporation 250 Clearbrook Road Elmsford, NY 10523
Phone: 941-592-6100 Fax: 941-592-6148
Contact Person: David Vozick Telephone: 914 542 6100 ext. 204
Date Prepared: August 21, 2007
2. DEVICE NAME
| Proprietary Name: | NewTom VG Computed Tomography X-Ray System |
|---|---|
| Common/Usual Name: | X-Ray System |
| Classification Name: | Computed Tomography X-Ray System |
3. PREDICATE DEVICES
NewTom 3G Computed Tomography X-Ray System K041137
4. DEVICE DESCRIPTION
The NewTom VG Computed Tomography X-Ray System (NewTom VG) is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images. It then reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of such volume, displaying both two- and three-dimensional images. The NewTom VG can measure distances and thickness on two-dimensional images. Such images can be printed or exported on magnetic and optical media.
1
The NewTom VG is designed for use in diagnostic support both in dento-maxillofacial radiology, with a particular reference to "planning" and to monitoring of implantations, and in the field of maxillofacial surgery.
The NewTom VG hardware, including a scanner unit (comprised of an X-ray source, flat panel detector and a motorized arm) and a control box. facilitates the acquisition of a full X-ray sequence by the device software. The NewTom VG software runs on an x86 architecture based workstation. The NewTom VG reconstructs a three-dimensional model of x-ray images similar to the threedimensional model obtained using the parent NewTom 3G Computed Tomography X-Ray System (NewTom 3G).
న్. INTENDED USE
The NewTom VG is a dedicated X-ray 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 NewTom VG accomplishes this task by 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.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The technological characteristics of the NewTom Computed Tomography X-ray System and the parent NewTom 3G Computed Tomography X-ray Systems are substantially equivalent in that they are devices designed to provide images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The proposed NewTom VG and the parent NewTom 3G are computer controlled dedicated x-ray imaging devices that construct three-dimensional models from images taken during a rotational x-ray sequence. It is optimized for bone morphology analysis of the maxillofacial region.
The proposed NewTom VG and the NewTom 3G both use an X-ray imaging system that acquires a 360 degrees rotational x-ray sequence and reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of this volume, displaying both two- and three-dimensional images.
The proposed NewTom VG hardware, including a control box and framework comprised of an x-ray source, detector and either a fixed or rotating arm whereas the NewTom 3G system consists of the same components with only a fixed arm. The
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proposed NewTom VG allows imaging to be performed in both a sitting and standing position and the parent NewTom 3G system only allows imaging to be performed in a supine position. The above differences do not impact safety or effectiveness since both the parent NewTom 3G and the proposed NewTom VG system are identical in that they are computer controlled dedicated x-ray imaging devices that constructs threedimensional models from images taken during a rotational x-ray sequence. The technological characteristics for both the proposed NewTom VG and the parent NewTom 3G devices provide the user with a method of constructing a threedimensional models from images taken during a rotational x-ray sequence. Therefore, the addition of hardware to improve image quality and flexibility of design represent minor technological differences that do not affect the overall safety or effectiveness of the proposed NewTom VG Computed Tomography X-ray System.
7. Performance Testing
Electrical safety, EMC/EMI testing, and verification and validation testing were performed to support the hardware and software modifications. The NewTom VG Computed Tomography X-Ray System met all requirements, and functioned as intended and is therefore safe and effective for its intended use.
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Image /page/3/Picture/0 description: The image shows a circular logo with the words "OF HEALTH & HUMAN SERVICES USA" written around the perimeter of the circle. Inside the circle is a symbol that appears to be three stylized lines that resemble a bird in flight. The logo is black and white and has a simple, clean design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 1 8 2007
AFP Imaging Corporation % Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant Medical Device Consultants. Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
Re: K072357
Trade/Device Name: NewTom VG Computer Tomography X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: August 21, 2007 Received: August 22, 2007
Dear Ms. McNamra-Cullinane:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "PA" in a stylized font. Below the letters, the word "Centennial" is written in cursive. Three stars are arranged in a horizontal line below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration.
Prossing and Promoting Publio Hoalth
4
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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology). | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: NewTom VG Computed Tomography X-ray System
Indications for Use:
The NewTom VG Computed Tomography X-ray System is a dedicated X-ray 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 NewTom VG accomplishes this task by 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C) প্লফ্ল্
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hels Perman
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number