(55 days)
No
The description details a traditional X-ray system with a microprocessor-controlled timer for setting exposure time based on tooth type and patient size. There is no mention of AI, ML, or advanced image processing capabilities beyond basic X-ray generation and timing.
No
The device is used for radiographic examination and diagnosis, which are diagnostic purposes, not therapeutic.
Yes
The device is intended for "radiographic examination and diagnosis of diseases of the teeth," indicating it is used to obtain information for diagnostic purposes.
No
The device description clearly outlines physical components such as a tubehead, arms, control panel, and wall mount kit, indicating it is a hardware device, not software-only.
Based on the provided information, the Elity 70 X-Ray 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 for diagnosis, monitoring, or screening.
- Elity 70 Function: The Elity 70 X-Ray is an imaging device that uses X-rays to create images of teeth for radiographic examination and diagnosis. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "extraoral X-ray recording media (Film, plates, sensors) for the purpose of radiographic examination and diagnosis of the teeth." This involves imaging the body directly, not analyzing samples.
Therefore, the Elity 70 X-Ray falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Elity 70 X-Ray is an extra oral source X-Ray system for dental radiographic examination and diagnosis of diseases of the teeth. The unit is intended for use in the dental clinic environment and used by trained dentists and/or assistants.
Intended Use for the Elity 70 X-Ray Unit: The Elity 70 is an extraoral device designed to expose intraoral X-ray recording media (Film, plates, sensors) for the purpose of radiographic examination and diagnosis of the teeth.
Product codes
EHD
Device Description
The Elity 70 X-ray Unit is a traditional extra oral radiographic system, designed to face the most demanding needs of the dental profession both when using traditional films and digital imaging receptor. The system voltage potential of 70kVp and the anodic current of 10 mA, the small focal spot, the beam limiting device with effective near focus collimation, and the penetration power of a 70 kVp radiation beam make the best combination of which grant sharp images. The Elity 70 X-Ray wall mounted system feature short, medium, and long extension arms giving a useful reach up to 185 cm when combined with the folding arm. The system comes with an Auto Set timer thus offering the best flexibility of use. Common functionality include a green light for "system ready", a vellow light and a buzzer for "radiation emission, and a red light for "faulty condition"; each timer and each hand switch can be remotely mounted. The high voltage generator is enclosed in a cover. A circular cone with a maximum diameter of 60 mm forms the beam-limiting device. The weight of the tubehead is 7.5 kg. The certified components may be assembled in different configurations in terms of arms and mounting.
Auto Set electronic timer microprocessor controlled, with flat keyboard; automatic setting of exposure time from 0.1 ms to 3.0 through objectprogrammed selection according to tooth type and patient size. Elity 70 extraoral X-ray equipment is composed of the following parts:
- I. Fixed and Scissor Arms.
- Tubehead with Beam Limiting Device. II.
- III. Control Panel (Timer)
- IV. Wall Mount Kit- Single post 16" Center Wall Plate.
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
trained dentists and/or assistants / dental clinic environment
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
JAN - 6 2005
Image /page/0/Picture/1 description: The image shows a logo for "Dental X-Ray". The text "Dental" is in a bold, sans-serif font, with a line extending from the top left corner. The text "X-Ray" is in a similar font, but smaller and slightly slanted. To the right of the text is a stylized image of a dental X-ray machine.
Dec 17, 2004
510(k) K043136 Summary
Applicant:
Dental X-Ray E.U. Calle 49 Sur Nº 43A 26-Local 301 Envigado Antioquia, Colombia Tel. 4-302-3535 - Fax. 4-302-4353 Owner/Operator Number: 9063785
Preparer:
Dental Products of USA, Inc. 1460 NW 107 Ave Suite G Miami, Florida 33172 Tel: 305-640-9894 Fax: 305-477-3206 Contact Person: George Echeverri Owner/Operator Number: 9034594
Summary Prepared Date:
Dec 17, 2004
Device Name:
| I. Proprietary Name: | Elity 70 X-Ray |
|---|---|
| II. Common/Usual Name: | Unit, X-Ray, Extraoral with Timer |
| III. Classification Name: | Unit, X-Ray, Extraoral with Timer |
Predicate Devices:
1
KO43136
Intended Use:
The Elity 70 X-Ray is an extra oral source X-Ray system for dental radiographic examination and diagnosis of diseases of the teeth. The unit is intended for use in the dental clinic environment and used by trained dentists and/or assistants.
Device Description:
The Elity 70 X-ray Unit is a traditional extra oral radiographic system, designed to face the most demanding needs of the dental profession both when using traditional films and digital imaging receptor. The system voltage potential of 70kVp and the anodic current of 10 mA, the small focal spot, the beam limiting device with effective near focus collimation, and the penetration power of a 70 kVp radiation beam make the best combination of which grant sharp images. The Elity 70 X-Ray wall mounted system feature short, medium, and long extension arms giving a useful reach up to 185 cm when combined with the folding arm. The system comes with an Auto Set timer thus offering the best flexibility of use. Common functionality include a green light for "system ready", a vellow light and a buzzer for "radiation emission, and a red light for "faulty condition"; each timer and each hand switch can be remotely mounted. The high voltage generator is enclosed in a cover. A circular cone with a maximum diameter of 60 mm forms the beam-limiting device. The weight of the tubehead is 7.5 kg. The certified components may be assembled in different configurations in terms of arms and mounting.
Auto Set electronic timer microprocessor controlled, with flat keyboard; automatic setting of exposure time from 0.1 ms to 3.0 through objectprogrammed selection according to tooth type and patient size. Elity 70 extraoral X-ray equipment is composed of the following parts:
- I. Fixed and Scissor Arms.
- Tubehead with Beam Limiting Device. II.
- III. Control Panel (Timer)
- IV. Wall Mount Kit- Single post 16" Center Wall Plate.
2
Image /page/2/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 stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing left, and the stripes are angled upwards. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2005
Dental X-Ray E.U. % Mr. George Echeverri Director Dental Products of USA, Inc. 1460 NW 107 Ave, Suite G MIAMI FL 33172
Re: K043136 Trade/Device Name: Elity 70 X-Ray Unit Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: December 17, 2004 Received: December 20, 2004
Dear Mr. Echeverri:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced abone 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.
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 I ca'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) (2) 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) I mis lotter vatification. The FDA finding of substantial equivalence of your device to a legally promated 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 11 you atter office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 :: 17: 17:11:21 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/cdrl/dsmadsmamain.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
4
Indications for Use
K 043136 510(k) Number (lf know):
Device Name: Elity 70 X-Ray
Statement of Indications for Use:
Intended Use for the Elity 70 X-Ray Unit:
The Elity 70 is an extraoral device designed to expose intraoral X-ray recording media (Film, plates, sensors) for the purpose of radiographic examination and diagnosis of the teeth.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
David h. Eymann
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices K045136 510(k) Number _