(122 days)
Not Found
No
The summary describes a standard X-ray generator and does not mention any AI or ML capabilities for image processing or analysis.
No
The device is an X-Ray generator for diagnostic imaging, not for therapeutic treatment. It assists in diagnosis by producing images of teeth, jaw, and oral structures.
Yes.
The device is an X-Ray generator designed for radiographic examination "to assist with diagnosis of diseases of the teeth, jaw, and oral structure".
No
The device description clearly states it is an X-Ray generator with a physical x-ray source (tube) and is a wall-mounted or floor model device, indicating it is a hardware device that utilizes software for control and operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BI IMAGE-X EVOLUTION device is an X-ray generator. Its function is to produce ionizing radiation that passes through the patient's body to create an image on a receptor. This is an in vivo process (occurring within the living body), not an in vitro process (occurring outside the living body).
- Intended Use: The intended use is for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. This involves imaging the internal structures of the patient's body directly.
Therefore, the device's function and intended use clearly place it outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The BI IMAGE-X EVOLUTION device is an X-Ray generator designed for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.
The BI IMAGE-X EVOLUTION is an extraoral x-ray generator system is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.
Product codes
EHD
Device Description
The device is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located outside the mouth. All three conventional types of intraoral receptors can be used with this device: analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The Bi Image-X Evolution is a wall mounted device or can also be a floor model on a stand. Choice of model is a matter of functional utility in the dental operatory and personal preference by the medical professional. The type of model used does not change the performance of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
teeth, jaw, and oral structure
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental 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)
Performance data: EMC and Electrical Safety – IEC 60601-1 3rd Edition (which include IEC test specifications: 60601-1-6, 60601-1-3, 60601-2-28) and EN 650601-1-2. The testing data reports for the subject device are provided in this petition. Tests were conducted by independent laboratory (Met Laboratories, Inc. 33439 Western Avenue, Union city, CA 94587. This device conforms to all applicable performance standards in 21CFR 1020.030 and 1020.31. Software - Software verification and validation testing and risk analysis assessment were performed by Radiotech and is a part of this submission.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2016
Radiotecnologia Industrial S.A. De C.V. % Claude Berthoin, President Denterprise International, Inc./ 510k FDA Consulting 100 East Granada Blvd Suite 219 Ormond Beach, FL 32176
Re: K160458
Trade/Device Name: BI IMAGE-X EVOLUTION Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: May 6, 2016 Received: May 10, 2016
Dear Claude 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 (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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/ResourcesforYou/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 Oaks
Robert Ochs, Ph.D. 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) K160458
Device Name
BI IMAGE-X EVOLUTION
Indications for Use (Describe)
The BI IMAGE-X EVOLUTION device is an X-Ray generator designed for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a black and white drawing of an eagle. The eagle is facing to the right, and its wings are spread out. The eagle's head is turned to the side, and its beak is open. The eagle's feathers are detailed, and the overall image is well-drawn.
510k FDA Consulting
Medical Device Clearance
100 East Granada Blvd., Suite 219
Ormond Beach, FL 32176
386-506-8711
510(k) Summary
Submitter/Applicant
Radiotecnologia Industrial S.A. de C.V. Calle Puebla Sur, Manzana 4 Lote 5 Colonia Jardin Industria Ixtapaluca, Estado de Mexico, Mexico 56535
Contact: Marcelo Mojica, Engineering Manager Telephone: (01) 800-681-05-38 Date Prepared: February 15, 2016
Preparer/Consultant
Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
Phone: 386-506-8711 Fax: 855-235-7902
| Primary Contact: | Joyce St. Germain, Regulatory Executive |
|---|---|
| Joyce@510kFDA.com | |
| Secondary Contract: | Claude Berthoin, President |
| Claude@510kFDA.com |
Device Classification
| Trade Name: |
|---|
| Common Name: |
| Classification Name: |
| Regulation Number: |
| Product Code: |
| Regulatory Class: |
| 510k Review Panel: |
BI IMAGE-X EVOLUTION Extraoral Source X-ray System Unit, X-Ray, Extraoral with Timer 21 CFR 872.1800 EHD 2 Dental
4
Predicate Device
The subject device claims equivalence to the following legally marketed predicate:
| 510(k) Number: | K122582 |
|---|---|
| Date Cleared | December 7, 2012 |
| Trade Name: | Dental X-Ray Z70 |
| Common Name: | Extraoral Source X-ray System |
| Classification Name: | Unit, X-Ray, Extraoral with Timer |
| Regulation Number: | 21 CFR 872.1800 |
| Product Code: | EHD |
| Regulatory Class: | 2 |
| 510k Review Panel: | Dental |
Indication for Use
The BI IMAGE-X EVOLUTION is an extraoral x-ray generator system is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.
Intended Use
The BI IMAGE -X EVOLUTION device is an extroral x-ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.
Device Description
The device is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located outside the mouth. All three conventional types of intraoral receptors can be used with this device: analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The Bi Image-X Evolution is a wall mounted device or can also be a floor model on a stand. Choice of model is a matter of functional utility in the dental operatory and personal preference by the medical professional. The type of model used does not change the performance of the device.
Different models neither affect the device's indications for use nor raise differing issues of safety or effectiveness.
Comparison of Technological data on next page
5
Characteristics with Predicate
The following table compares technological and other characteristics of the subject and predicate device.
Table 5 -- Technological Comparison
| | Subject Device | Predicate Device
K122582 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | BI IMAGE-X | Dental X-Ray Z70 |
| 510(k) Owner | Radiotecnologia
Industrial S.A. de C.V.
(Mexico) | XZeal Technologies, Inc.
(Kissimmee, FL) |
| Classification & Product
Code | 872.72.1800; EHD | 872.1800; EHD |
| Device Description | Extroral x-ray system
used for dental
radiographic
examinations and
diagnosising. | Extroral x-ray system
used for dental
radiographic
examinations and
diagnosising. |
| Common Name | Extraoral Source X-ray
System | Extraoral Source X-ray
System |
| Models | Wall Mount, Mobile
and Column Units | Wall Mount, Mobile
and Column Units |
| Indication for Use | The BI IMAGE-X
EVOLUTION is an
extraoral x-ray
generator system is
designed to be used by
dental professionals for
radiographic
examinations to assist
with diagnosis of
diseases of the teeth,
jaw, and oral structure
in combination with an
intraoral image
receptor. | TheDental X-ray Z70
device is an X-Ray
generator that
provides the radiation
necessary for the
formation of a
radiographic image
from which a
radiographic diagnosis
may be made. |
| Intended Use | The BI IMAGE -X
EVOLUTION device is an
extraoral x-ray
generator that provides
the radiation necessary
for the formation of a
radiographic image
from which a | Extraoral source X-ray
system for dental
radiographic
examination and
diagnosis of diseases
of the teeth. |
| | radiographic diagnosis
may be made. | |
| Electric Power Voltage | 108-132 VAC Monophase
rectified | 120 VAC ± 10% or
230 VAC ± 10% |
| Rated Current | 10A max (120V) | 9 A (120V) - 4A (230V) |
| Type of Power Supply | 50/60 Hz | 50/60 Hz |
| kVp (kilovolt peak) | 70 kVp +/- 15% with 108-
132 V | 70 kVp ± 10% |
| Exposure Time | 0.01-2.2 sec | 0.06 — 2.50 sec |
| Current to Tube | 10 mA +/- 20% | 7 mA ± 1.40 |
| Maximum Radiation Field | Ø 60 mm | Ø 60 mm |
| Focal Point | 0.8mm (IEC366) | 0.8 mm x 0.8 mm
(IEC 336) |
| X-Ray Generator | AC - Alternate Current | AC - Alternate Current |
| Operator Exposure Control | Deadman Switch | Deadman Switch |
| Exposure Interval
(Duty Cycle) | 1:32 | 1:60 |
| Minimum Distance
between the source and
the skin - SSD | 20 cm | 20 cm |
| Fuses | 10A 250V | 10A 230V |
| Operatiang Temperature
Range | -20°C - + 70°C | -20°C - + 55°C |
| Fixed Arm | 27.56 inches (70 cm) | 27.56 inches (70 cm) |
| Standards of Conformity | IEC 60601-1
IEC 60601-6
IEC 60601-3
IEC 60601-2-28
EN 60601-1-2 | EN 60601-1
EN 60601-2-28
EN 60601-2-54
EN 60601-1-3
EN 60601-1-2 |
6
The above comparison shows the subject and predicate devices have substantially similar technology characteristics.
7
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
EMC and Electrical Safety – IEC 60601-1 3rd Edition (which include IEC test specifications: 60601-1-6, 60601-1-3, 60601-2-28) and EN 650601-1-2. The testing data reports for the subject device are provided in this petition. Tests were conducted by independent laboratory (Met Laboratories, Inc. 33439 Western Avenue, Union city, CA 94587.
This device conforms to all applicable performance standards in 21CFR 1020.030 and 1020.31.
Software - Software verification and validation testing and risk analysis assessment were performed by Radiotech and is a part of this submission.
Risk Analysis Information
Risk analysis includes particular recommendations to address radiation exposure to the user under mobile operating conditions. Operators should always read the user manuals for medical devices and take the necessary precautions before using the device. Methods to reduce exposure is recommended safety precautions such as wearing personnel monitoring and protective equipment.
Conclusion
The subject and the predicate device have the same intended use and the same technological features. The BI IMAGE – X and the Dental X-Ray Z70 share the same principles of operation and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate.
The BI IMAGE - X warrants a finding of substantial equivalence to the legally marketed Dental X-Ray Z70 and thus clearance for premarket activities in the United States.