(14 days)
Not Found
No
The summary describes standard image reconstruction techniques for a CT scanner and does not mention any AI or ML capabilities.
No.
The device is described as an X-ray imaging system for diagnostic support, which is used for acquiring images and reconstructing a three-dimensional model for analysis, rather than for treating a disease or condition.
Yes
The device is described as providing "diagnostic support in odontoiatric radiology" and "in the field of maxillofacial surgery," clearly indicating its use for diagnosis.
No
The device description explicitly states it includes hardware components such as an X-Ray imaging system, a patient table, and a gantry (comprised of an X-ray Source, image chain, and a motorized arm).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the NewTom QR-DVT 9000 is an X-ray imaging device. It acquires X-ray sequences and reconstructs images of the patient's anatomy (specifically the odontoiatric and maxillofacial regions).
- No Mention of Samples: There is no mention of the device analyzing biological samples or performing tests on them. Its function is purely based on capturing and processing X-ray images of the patient's body.
Therefore, the NewTom QR-DVT 9000 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NewTom QR-DVT 9000 Computed Tomography X-ray System is a dedicated X-Ray imaging device that acquires a 360-degree rotational X-Ray sequence for use in diagnostic support in odontoiatric radiology (with a particular reference to patient chaghestion and the monitoring of implantations) and in the field of maxillofacial surgery. This is the same intended use as previously cleared for the NewTom QR-DVT 9000 Computed Tomography X-ray System, [510 (k) #K003787].
The NewTom QR-DVT 9000 accomplishes this task by reconstructing a threedimensional matrix of the examined volume and producing two-dimensional vicws of this volume, displaying both two- and three-dimensional images.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
The NewTom 3G is a dedicated X-Ray imaging device that uses an X-Ray imaging system and a patient table. The NewTom 3G acquires a 360-degree rotational X-Ray sequence, 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 NewTom 3G can measure distances and thickness on two-dimensional images.
Images produced by the NewTom 3G can be printed or exported on magnetic and optical media.
The Newlom 3G hardware, including a patient table and a gantry (comprised of an X-ray Source, image chain and a motorized arm) facilitates the acquisition of a full X-Ray sequence by the device's software. The NewTom software runs either in a Windows 2K or Windows XP workstation.
The NewTom 3G is an X-Ray imaging device that constructs a three-dimensional model from images taken during a rotational X-Ray sequence. The NewTom 3G is optimized for bone morphology analysis on the maxillofacial region.
The NewTom 3G reconstructs a three-dimensional model for X-Ray images similar to the three-dimensional model obtained using the original NewTom X-Ray system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
maxillofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
odontoiatric radiology
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)
The determination of substantial equivalence of the predicate device has been based upon the comparison of machine specifications and not upon clinical and/or nonclinical performance data, thus 21 C.F.R. Part 807.92(b) does not apply.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image shows the word "APERIO" in a sans-serif font. A curved line is drawn above the word, starting from the left side of the "A" and ending on the right side of the "O". The text and the curved line are both black, and the background is white.
MAY 1 4 2004
Special 510(k) Summary
April 28, 2004
This 510(k) Summary has been prepared by the following submitter (who also acts as the United States Distributor of the NewTom model QR-DVT 9000):
Address and Registration Number of Submitter/Distributor:
Aperio Services, LLC 950 South Tamiami Trail; Stc.#102 Sarasota, FL 34236 Tel. # (941) 955-2885 Fax. # (941) 955-2884 Contact: K. Robert Wisner, Esq. Distributor's Registration Number: 2438913
Address and Registration # of the Manufacturer:
NIM S.r.l. Via Silvestrini 20 Verona, Italy 37135 Manufacturer's FDA Registration #: 3003310161
Device Trade Name:
NewTom 3G model QR-DVT 9000
Common/Classification Name:
Computed Tomography X-ray System
Predicate Device Information:
The predicate device is the NewTom model QR-DVT 9000 Computed Tomography X-ray System, [510(k) # K003787] this predicate device has been has been classified as Class II, 90 JAA/ 90MUH. The NewTom 3G model QR-DVT 9000 is substantially equivalent to the NewTom model OR-DVT 9000.
Device Description and Intended Use:
The device description of the NewTom 3G model QR-DVT 9000 Computed Tomography X-ray System is as follows:
The NewTom 3G is a dedicated X-Ray imaging device that uses an X-Ray imaging system and a patient table. The NewTom 3G acquires a 360-degree rotational X-Ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of this volume,
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displaying both two- and three-dimensional images. The NewTom 3G can measure distances and thickness on two-dimensional images.
Images produced by the NewTom 3G can be printed or exported on magnetic and optical media.
The NewTom 3G is designed for use in diagnostic support both in odontoiatric radiology, with a particular reference to "planning" and to monitoring of implantations, and in the field of maxillofacial surgery.
The Newlom 3G hardware, including a patient table and a gantry (comprised of an X-ray Source, image chain and a motorized arm) facilitates the acquisition of a full X-Ray sequence by the device's software. The NewTom software runs either in a Windows 2K or Windows XP workstation.
The NewTom 3G is an X-Ray imaging device that constructs a three-dimensional model from images taken during a rotational X-Ray sequence. The NewTom 3G is optimized for bone morphology analysis on the maxillofacial region.
The NewTom 3G reconstructs a three-dimensional model for X-Ray images similar to the three-dimensional model obtained using the original NewTom X-Ray system.
Comparison of Technological Characteristics with the Predicate Device:
The NewTom 3G model OR-DVT 9000 Computed Tomography X-ray System is a dedicated X-Ray imaging device that acquires a 360-degree rotational X-Ray sequence for use in diagnostic support in odontoiatric radiology (with a particular reference to patient evaluation and the monitoring of implantations) and in the field of maxillofacial surgery. This is the same intended use as previously cleared for the New Tom model QR-DVT 9000 Computed Tomography X-ray System, [510 (k) #K003787].
Further, the NewTom 3G model QR-DVT 9000 is substantially similar to the NewTom model QR-DVT 9000 which previously received 510(k) concurrence in the following ways, both machines:
- have the same indicated use;
- use the same opcrating principle; .
- incorporate the same basic technology; .
- incorporate the same materials. .
The determination of substantial equivalence of the predicate device has been based upon the comparison of machine specifications and not upon clinical and/or nonclinical performance data, thus 21 C.F.R. Part 807.92(b) does not apply.
2
Conclusion:
The NewTom 3G model OR-DVT 9000 acquires an X-ray rotational sequence and provides three-dimensional information on the analyzed volume. The potential hazards (c.g., electrical, mechanical, thermal, radiation, incorrect measurement and misdiagnosis) are controlled by the NewTom's risk management system including:
- A hazard analysis performed according to a fault tree which indicates an . extremely low probability of harmful events;
- A hardware an software development and validation process under EN 46001-● ISO 13485 quality system;
- Adherence to International Standards- International Electrotechnical ● Commission (IEC); and
- Adherence to U.S. Standards 21 CFR 1020.33. .
The New Tom 3G model QR-DVT 9000 is an x-ray imaging system that complies with requirements of 21 C.F.R. Part 807.87(h), and does not pose any new safety risks or effectiveness issues.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and tail. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. K. Robert Wisner, Esq. Corporate Counsel Aperio Services, LLC 950 South Tamiami Trail, Suite 102 SARASOTA FL 34236
AUG 23 2013
Re: K041137
Trade/Device Name: NewTom 3G OR-DVT 9000 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: April 28, 2004 Received: April 30, 2004
Dear Mr. Wisner:
This letter corrects our substantially equivalent letter of May 14, 2004.
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 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 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 Parts 801 and 809); medical device reporting (reporting of
4
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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 Statement
510(k) Number:
The original NewTom QR-DVT 9000 (predicate device) 510(k) Number is: K003787. The NewTom 3G QR-DVT 9000 number is not yet available.
Device Name:
NewTom 3G QR-DVT 9000 Computed Tomography X-ray System
Indications for Use:
The NewTom QR-DVT 9000 Computed Tomography X-ray System is a dedicated X-Ray imaging device that acquires a 360-degree rotational X-Ray sequence for use in diagnostic support in odontoiatric radiology (with a particular reference to patient chaghestion and the monitoring of implantations) and in the field of maxillofacial surgery. This is the same intended use as previously cleared for the NewTom QR-DVT 9000 Computed Tomography X-ray System, [510 (k) #K003787].
The NewTom QR-DVT 9000 accomplishes this task by reconstructing a threedimensional matrix of the examined volume and producing two-dimensional vicws of this volume, displaying both two- and three-dimensional images.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ OR Over-The-Counter Use ______ |
|---|---|
| (Per 21 CFR 801. 109) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K041137 |
|---|---|
| --------------- | --------- |
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