(34 days)
Not Found
No
The summary describes a standard CBCT system with a 3D reconstruction engine, and there are no mentions of AI, ML, or related concepts.
No.
The device is described as an x-ray system intended for examination and diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." This directly indicates its role in diagnosing conditions.
No
The device description explicitly states it is a "three dimensional Cone Beam Computed Tomography (CBCT) x-ray system" and describes hardware components like an "x-ray system add on," "flat panel sensor," and "x-ray generator." This indicates it is a hardware device with integrated software, not a software-only medical device.
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 Planmeca Promax 3D is an imaging system that uses X-rays to create images of the teeth, jaw, and oral structures. It does not analyze biological samples.
- Intended Use: The intended use is for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures" through imaging.
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Planmeca Promax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals.
Product codes
MUH
Device Description
The Planmeca Promax 3D is in principle a conventional digital panoramic x-ray system with three-dimensional Cone Beam Computed Tomography (CBCT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cone Beam Computed Tomography (CBCT) x-ray
Anatomical Site
teeth, jaw, and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and other legally qualified 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)
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
PLANMECA
ENCLOSURE 12
P. 12-1
KOGO328
MAR 1 5 2006
510K) SUMMARY
DATE February 7, 2006
PRODUCT, CLASSIFICATION NAME
Trade name: Planmeca Promax 3D Common name: Panoramic/Tomography x-ray system Classification: 76 EHD, Class II Regulation number: 872.1800
MANUFACTURER
Planmeca Oy Asentajankatu 6 FI-00880 Helsinki, Finland Phone: +358 20 7795 500 Fax: +358 20 7795 396 Contact person: Lars Moring
UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)
Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 529 2300 Fax: (630) 529 1929 Contact person : Bob Pienkowski
INTENDED USE
Planmeca Promax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals.
PRODUCT DESCRIPTION
The Planmeca Promax 3D is in principle a conventional digital panoramic x-ray system with three-dimensional Cone Beam Computed Tomography (CBCT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.
1
SUBSTANTIAL EQUIVALENCE
We consider this product modification including a new 3D CBCT x-ray system to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976:
3D Accu-i-tomo XYZ Slice View Tomograph # K052587
The comparison of characteristics supports substantial equivalence. Planmeca Promax 3D is as safe and effective as the predicate device.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
Mr. Lars Moring Regulatory Affairs Manager Planmeca Oy Asentajankatu 6 FI-00880 Helsinki FINLAND
Re: K060328 Trade/Device Name: Planmeca Promax 3D Regulation Number: 21 CFR 872.1800
Regulation Name: Extraoral source x-ray system Regulatory Class: II
Product Code: MUH Dated: February 7, 2006 Received: February 9, 2006
Dear Mr. Moring:
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 mav, 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 CJFR 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.
Image /page/2/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
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 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act irom 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/industry/support/index.html
Sincerely vours.
Nancy C. Bigelow
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
510(k) Number (if known):
Planmeca Promax 3D Device Name:
Indications For Use:
Planmeca Promax 3D, is a three dimensional Cone Bearn Computed Planmeca I Tomax 62, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Tomography (ODOT) X-18) System, will in and diseases of the teeth, jaw, radiographic examination and concess cone shaped x-ray beam and oral structures. The de notector, and the examined volume image projected on to a hat parter dotor, anving stations. The device is to
is reconstructed to be viewed in 3D viewing stations welf on is reconstructed to be views the research and other legally qualified professionals.
Prescription Use
(Part 21 CFR 801 Subpart D)
... ... ...
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eötvös L. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
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