(40 days)
Explor-X 70
Not Found
No
The description focuses on the hardware components and basic microprocessor control of exposure times, with no mention of AI or ML capabilities for image processing, diagnosis, or other functions.
No
The device is described as a Dental X-Ray generator used for radiographic examination and diagnosis, which are diagnostic purposes, not therapeutic.
Yes
The device is used for radiographic examination and diagnosis of dental anatomy, which are diagnostic purposes.
No
The device description clearly details a physical X-ray generator with hardware components like a tubehead, high voltage generator, beam-limiting device, and control box. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- This device is a Dental X-Ray generator. Its purpose is to generate X-rays that pass through the patient's dental anatomy to create images for diagnosis.
- The intended use clearly states "extra oral The melodelen for use in dentistry as required for the radiographic examination and diagnosis of the dental anatomy." This describes an imaging procedure performed directly on the patient, not on a specimen.
Therefore, the Corix 70 Plus-USV is a medical imaging device, specifically a dental X-ray machine, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Corix 70 Plus-USV is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
The indication for use of the Corix 70 Plus-USV (with DPM timer) is extra oral The melodelen for use in dentistry as required for the radiographic examination and diagnosis of the dental anatomy.
Product codes
90 EHD
Device Description
Corix 70 Plus-USV is a Dental X-Ray generator; its primary use is for intra oral image receptor radiology. For such application, a peak voltage of 70 kVp has been demonstrated to give a high quality film with a good film quality/risk ratio. This is also enhanced by the fact that the tube current has the value of 8 mA, assuring effectiveness.
The soft X-Ray are filtered by the inherent filtration and by an additional filter to guarantee the minimum 2 mm eq. of Al required by specifications.
Exposure times are microprocessor controlled, assuring a high constancy and also repeatability.
The high voltage generator is enclosed in a cover. The beam-limiting device is formed by a circular cone with a maximum diameter of 60 mm. The weight of the tubehead is 7.5 kg. The certified components may be assembled in different configurations in terms of arms and mounting.
The control box assembly and the timer are combined as one and include all the electronics to power the high voltage transformer contained on the tubehead.
plastic prismatic cover. X-Ray exposures are signaled by both acoustic and optical signals. The operator may choose exposure times ranging from 0.03 up to 3.00 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Teeth, dental anatomy
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Explor-X 70
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
KO3180Z
510K Summary
| Date: | April 21, 2003 |
|---|---|
| Applicant | Coramex S.A. |
| Lauro Villar 94-B | |
| 02440 - Mexico, D.F. Mexico | |
| Registration Number: 9613804 | |
| Contact Person | Massimo Bachi - President |
| Telephone (Applicant) | 011-52-55-5394-1192 |
| Device Name: | Corix 70 Plus-USV |
| Common Name: | X-Ray |
| Classification Name: | Unit, X-Ray, Extraoral |
| Legally Marketed device to which firm is | |
| claiming equivalence: | Explor-X 70 |
| Description of the Device: | Corix 70 Plus-USV is a Dental X-Ray |
| generator; its primary use is for intra oral | |
| image receptor radiology. For such | |
| application, a peak voltage of 70 kVp has | |
| been demonstrated to give a high quality | |
| film with a good film quality/risk ratio. | |
| This is also enhanced by the fact that the | |
| tube current has the value of 8 mA, | |
| assuring effectiveness. | |
| The soft X-Ray are filtered by the inherent | |
| filtration and by an additional filter to | |
| guarantee the minimum 2 mm eq. of Al | |
| required by specifications. | |
| Exposure times are microprocessor | |
| controlled, assuring a high constancy and | |
| also repeatability. | |
| The high voltage generator is enclosed in a | |
| cover. The beam-limiting device is formed | |
| by a circular cone with a maximum | |
| diameter of 60 mm. The weight of the | |
| tubehead is 7.5 kg. The certified | |
| components may be assembled in different | |
| configurations in terms of arms and | |
| mounting. | |
| The control box assembly and the timer are | |
| combined as one and include all the | |
| electronics to power the high voltage | |
| transformer contained on the tubehead. | |
| plastic prismatic cover. X-Ray exposures | |
| are signaled by both acoustic and optical | |
| signals. The operator may choose exposure | |
| times ranging from 0.03 up to 3.00 | |
| seconds. | |
| Intended use of the device: | Corix 70 Plus-USV is an extra oral source |
| X-ray system for dental radiographic | |
| examination and diagnosis of diseases of | |
| the teeth. |
1
Summary of the Technological characteristics of Corix 70 Plus-USV compared to the predicate device Explor-X 70.
| Explor-X 70 | Corix 70 Plus-USV | |
|---|---|---|
| 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 | $70 kV_p$ | $70 kV_p$ |
| Tube current | 8 mA | 8 mA |
| Tube insert | CEI OCX 70-G | CEI OX/ 70-P |
| 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 | Automatically by software | Automatically by software |
| Safety features | Dead man command | |
| Safety backup timer | Dead man command | |
| Safety backup timer Safety | ||
| backup timer | ||
| Signaling devices | Acoustic and visual signal | |
| Optional remote signaling | Acoustic and visual signal | |
| Optional remote signaling |
The main differences of the Corix 70 Plus-USV with respect to the SE device are mainly aesthetics. The functionality and technology are simi!ar
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Coramex S.A. % Mr. Al Sosa Chicago X-Ray Systems, Imc. 251 E. Dundee Road, Suite # 6 WHEELING IL 60090
Re: K031802
Trade/Device Name: Corix 70 Plus-USV Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: April 21, 2003
Received: June 13, 2003
Dear Mr. Sosa:
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. Iisting 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 (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); 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.
3
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
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
to proceed to the market.
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510 (k) NUMBER: K031802 Corix 70 Plus-USV DEVICE NAME: INDICATIONS FOR USE:
The indication for use of the Corix 70 Plus-USV (with DPM timer) is extra oral The melodelen for use in dentistry as required for the radiographic examination and diagnosis of the dental anatomy.
(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 Formay 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K031802 |
|---|---|
| --------------- | --------- |
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