(26 days)
Gendex 765DC, Planmeca Prostyle Intra, Trophy Elitys
Not Found
No
The description focuses on the hardware components and fixed operational parameters of a standard X-ray device, with no mention of AI/ML for image processing, analysis, or other functions.
No
The device is an extraoral source of x-rays used for imaging within dentistry, which performs a diagnostic function rather than directly treating a disease or condition.
No.
The device is described as an "extraoral source of x-rays" for imaging the dento-maxillofacial area. It generates x-rays for imaging, but it does not perform any analysis, interpretation, or diagnosis of the acquired images. It is a tool for image acquisition, not for diagnosis itself.
No
The device description explicitly lists multiple hardware components (X-ray tube head, Yoke, Articulated arm, etc.) and describes it as an extraoral source of x-rays, indicating it is a physical hardware device.
No, 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 KaVo In eXam Intraoral X-ray device is an extraoral source of x-rays used for imaging the dento-maxilofacial area. It generates radiation that passes through the body to create an image, rather than analyzing a sample taken from the body.
- Intended Use: The intended use clearly states it's for use within dentistry as an extraoral source of x-rays. This is a diagnostic imaging device, not a device that performs tests on biological samples.
Therefore, based on the provided information, the KaVo In eXam Intraoral X-ray device is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KaVo In eXam Intraoral X-ray device is to be used exclusively within dentistry as an extraoral source of x-rays.
The KaVo In eXam Intraoral Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.
Product codes
EHD
Device Description
The KaVo In eXam Intraoral Dental X-Ray System is an extraoral source of x-rays for imaging of the dento-maxilofacial area.
The KaVo In eXam Intraoral Dental X-Ray System is comprised of the following main components:
- X-ray tube head .
- . Yoke with user interface capabilities
- . Articulated arm
- . Horizontal arm
- Electronic control unit .
- Wall mount .
- Cone .
The power supply is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 7mA. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of expsure time is 0.012 through 1.88 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays
Anatomical Site
dento-maxilofacial area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentistry
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)
Safety and Effectiveness is demonstrated by:
- Performance testing to meet product specifications
- Software testing to validate software design / performance
- Effective clinical image exposures
- Hazard analysis including risk level and solution
- Same indications for use as predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Gendex 765DC, Planmeca Prostyle Intra, Trophy Elitys
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/2 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. Inside the circle are three stylized shapes that resemble birds in flight.
MAR 2 1 2005
Mr. John R. Miller Director, Ouality Assurance and Regulatory Affairs KaVo America 340 East Main Street LAKE ZURICH IL 60047
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K050019 Trade/Device Name: In eXam Intraoral Dental X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: January 4,2005 Received: January 5,2005
Dear Mr. Miller:
This letter corrects our substantially equivalent letter of January 31,2005, that contained an incorrect panel code for the In eXam Intraoral Dental X-ray System. The product code (EHD) was correct. It was the panel code (90) that was incorrect. Since we are in the process of deleting panel codes from substantially equivalent letters, we are revising this letter to reference only the product code.
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 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 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
1
Page 2 – Mr. John R. Miller
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.
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 Part 801), please contact the 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 regulationentitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours.
Nancy C. Brogdon
Nancv C. B odon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number(if known): Not Assigned
Device Name :
In eXam Intraoral Dental X-Ray System
Indications for Use:
The KaVo In eXam Intraoral X-ray device is to be used exclusively within dentistry as an extraoral source of x-rays. -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
V Prescription Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Over-The-Counter Usc _
Jame's Heplin
(Division Sign-Off) Division Sign-Oiverive, Abdominal, 0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . n : . Axj Number
∅∅39
(Replacement)
3
K0500019
JAN 3 1 2005
510(k) Summary Statement for the KaVo In eXam Intraoral Dental X-Ray System
General Information I
| Submitter: | KaVo America
340 East Main
Lake Zurich, IL 60047 |
|-----------------|----------------------------------------------------------------------|
| Telephone: | (800) 323-8029 – Company Number
(847) 640-4924 - Contact Person |
| Fax: | (847) 640-4970 |
| Contact Person: | John R. Miller
Director, Quality Assurance and Regulatory Affairs |
Summary Preparation Date: December 7, 2004
II Names
KaVo In eXam Intraoral Dental X-Ray System Device Name: Primary Classification Name: 90EHD – Unit, X-Ray, Extraoral with Timer
III Predicate Devices
- Gendex 765DC .
- Planmeca Prostyle Intra .
- . Trophy Elitys
IV Product Description
The KaVo In eXam Intraoral Dental X-Ray System is an extraoral source of x-rays for imaging of the dento-maxilofacial area.
4
The KaVo In eXam Intraoral Dental X-Ray System is comprised of the following main components:
- X-ray tube head .
- . Yoke with user interface capabilities
- . Articulated arm
- . Horizontal arm
- Electronic control unit .
- Wall mount .
- Cone .
The power supply is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 7mA. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of expsure time is 0.012 through 1.88 seconds.
V Indications for Use / Rationale for Substantial Equivalence
The KaVo In eXam Intraoral Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.
It shares the same indications for use, similar materials, design, operational, and functional features and therefore is substantially equivalent to the predicate devices listed in section III of this summary.
5
VI Safety and Effectiveness Information
Safety and Effectiveness is demonstrated by:
- Performance testing to meet product specifications
- Software testing to validate software design / performance
- Effective clinical image exposures
- Hazard analysis including risk level and solution
- Same indications for use as predicate devices.
All the above steps and evaluations combine to demonstrate that the Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is safe and effective when the device is used as labeled.
VII Conclusion
The Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System was found to be is Substantially Equivalent to the predicate devices; the Pelton & Crane Orthophos Plus, the Planmeca PM 2002 CC Proline, the Instrumentarium Imaging Orthorpantomograph® OPD, and the Gendex Orthoralix SD2/Ceph and S/Ceph. The Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled.