(24 days)
Not Found
No
The description details a standard dental X-ray system with electronic controls and a microprocessor for exposure time calculation and line voltage compensation using a mathematical algorithm. There is no mention of AI or ML technologies for image processing, diagnosis, or other functions.
No
The device is used for diagnosis of diseases of the teeth using X-rays, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for "diagnosis of diseases of the teeth."
No
The device description clearly details physical hardware components such as an X-Ray generator, tubehead, arms, and a control timer with physical displays and buttons. While it mentions a microprocessor and a mathematical algorithm for voltage compensation, the core functionality and description are centered around the physical X-ray system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth." This describes an imaging device used to visualize structures within the body (in this case, teeth and surrounding areas) for diagnostic purposes.
- Device Description: The description details an X-ray generator and its components, all related to producing and directing X-rays for imaging.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with or analyze such specimens.
Therefore, the Aztech 70 is a medical imaging device, specifically a dental X-ray system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
Product codes
EHD
Device Description
Aztech 70 is a Dental X-Ray generator; its primary use is for intra oral image receptor radiology. with a peak voltage of 70 kVp and a tube current of 8 mA. The soft X-Ray are filtered by 2 mm eq. of Al.
The high voltage generator is enclosed in a plastic cover, with an apparently cylindrical aspect. The beam limiting device is formed by a circular cone with a maximum diameter of 6 cm.
The tubehead is mounted on a oval shaped scissors arm, spring balanced. The scissors arm has a length of about 60 cm for each arm. The arm is mounted on an extension arm, that on the standard version has a length of 90 cm: optional configurations are available using extension arm of different lengths (75 and 60 cm).
The unit is marketed as a wall mount permanent equipment. The electronic control of the VCA timer offers operator the possibility to select between automatic and manual selection of exposure times. In the automatic mode, selected exposure times according to the tooth. patient type (adult or child) and patient size to be filmed can be selected. With the manual mode of the VCA timer, the operator has the possibility to choose exposure times in steps ranging from 0.02 up to 3.2 seconds in discrete step increments.
The exposure time is displayed on the timer main box by a three digit LEDs display, both for automatic and manual selection. This display is also used to show error codes, to inform the operator about the various possible faults. The microprocessor has also the job to compensate the line voltage fluctuations by changing the exposure time. This feature is accomplished by a mathematical algorithm. with a non linear function.
X-Rav exposures are signaled by both acoustic and optical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
teeth
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
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)
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
Image /page/0/Picture/1 description: The image is a logo for Villa Sistemi Medicali. The logo consists of a stylized letter "V" in white against a black square. Below the square, the words "VILLA," "SISTEMI," and "MEDICALI" are stacked vertically in a simple, sans-serif font. The overall design is clean and modern.
Annex 1 - 510 (k) SUMMARY
510(k) summary for Aztech 70
Identification
| Applicant | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan- Italy |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person | dr. Francesco Attuati |
| Telephone (applicant) | + 39 2 488591 |
| Official Correspondent | Chicago X-Ray Systems, Inc.
Wheeling, IL 60090 |
| Contact Person | Al SOSA - President |
| Telephone
(contact person) | 847 - 459 3889 |
| Initial distributor in the
US | The Aztech Group, Inc.
1401 Walnut Street - suite 565
Boulder - Colorado 80302
Registration Number: 1722809 |
| Contact Person | Robert Padgett - President |
| Manufacturing site | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan - Italy |
Trade name: Aztech 70
Common name: Aztech 70 with VCA timer
Classification name: according to 21 CFR 872-1800, Aztech 70 device is in Class II.
Substantial equivalent device: the proposed equipment is defined as Substantially Equivalent (SE) to the Aztech 65 with CCD timer (K950667). This assumption is based on the comparison table contained on the following page.
1
| | Aztech 65 with CCD
Timer (K950667) | Aztech 70 with VCA
Timer |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Intended use | extra oral source X-ray
system for dental
radiographic examination
and diagnosis of diseases
of the teeth | extra oral source X-ray
system for dental
radiographic examination
and diagnosis of diseases of
the teeth |
| High Voltage value | 65 kVp | 70 kVp |
| Tube current | 8 mA | 8 mA |
| Tube insert | CEI OCX 70-G | CEI OCX 70-G |
| H.V. type: | Single phase, self
rectifying | Single phase, self rectifying |
| X-Ray exposure
time control | Microprocessor
Controlled | Microprocessor Controlled |
| Compensation of
Line Voltage
Fluctuations | Yes, automatically by
software algorithm | Yes, automatically by
software algorithm |
| Safety features | Dead man command | Improved controls, with
feedback sensors
Dead man command
Safety backup timer (HW) |
| Signaling devices | Acoustic and visual signal | Acoustic and visual signal
Optional remote signaling |
The main differences between the proposed equipment and the substantially equivalent one are listed in the following points:
- · the application of line voltage to the tubehead is microprocessor controlled
- · the ON/OFF switching of the main is controlled through-out the complete cycle
- · the user is requested to "enable" the emission by pushing the specific button; this feature, that can be selected by the service engineer, is particularly useful for the remote activation.
- the timer is ready to accept an optional remote signaling of X-Ray emission
- a safety back up timer, capable of inhibitin X-ray emission, independent from the microprocessor control, is provided in order to increase safety.
Aztech 70 description
2
Aztech 70 is a Dental X-Ray generator; its primary use is for intra oral image receptor radiology. with a peak voltage of 70 kVp and a tube current of 8 mA. The soft X-Ray are filtered by 2 mm eq. of Al.
The high voltage generator is enclosed in a plastic cover, with an apparently cylindrical aspect. The beam limiting device is formed by a circular cone with a maximum diameter of 6 cm.
The tubehead is mounted on a oval shaped scissors arm, spring balanced. The scissors arm has a length of about 60 cm for each arm. The arm is mounted on an extension arm, that on the standard version has a length of 90 cm: optional configurations are available using extension arm of different lengths (75 and 60 cm).
The unit is marketed as a wall mount permanent equipment. The electronic control of the VCA timer offers operator the possibility to select between automatic and manual selection of exposure times. In the automatic mode, selected exposure times according to the tooth. patient type (adult or child) and patient size to be filmed can be selected. With the manual mode of the VCA timer, the operator has the possibility to choose exposure times in steps ranging from 0.02 up to 3.2 seconds in discrete step increments.
The exposure time is displayed on the timer main box by a three digit LEDs display, both for automatic and manual selection. This display is also used to show error codes, to inform the operator about the various possible faults. The microprocessor has also the job to compensate the line voltage fluctuations by changing the exposure time. This feature is accomplished by a mathematical algorithm. with a non linear function.
X-Rav exposures are signaled by both acoustic and optical devices.
Indication for use.
The indication for use of the Aztech 70 is: extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth..
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Al Sosa Official Correspondent The Aztech Groups, Inc. 1401 Walnut Street, Suite 565 Boulder, Colorado 80302
K984524 Aztech 70 Dated: December 9, 1998 Received: December 21, 1998 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Sosa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
Re:
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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510 (K) NUMBER (IF KNOWN): K984524
DEVICE NAME: AZTECH 70
INDICATIONS FOR USE:
The Aztech 70 is intended for extra oral source X-ray system for dental radiographic examination and diagnosis of deseases of the teeth.
(PLEASE DO NOT WRITE BELOW – CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter-Use |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .