(41 days)
Not Found
No
The description mentions "Statistical Inversion (SI)" for image reconstruction, which is a standard computational technique, not explicitly AI or ML. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an imaging system used to produce images for diagnostic purposes (dental implant planning, locating impacted teeth), not to treat a condition.
Yes
Explanation: The device is described as producing "cross-sectional (tomographic) radiographic images" and providing "dimensional information for dental implant planning and information about location of impacted teeth," which are uses consistent with diagnostic imaging.
No
The device description explicitly states that it utilizes a digital panoramic unit to capture projection images, which is a hardware component. The software then reconstructs tomographic images from these pre-acquired images.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is used to produce radiographic images of the jaws. It is an imaging device that works directly on the patient, not on a biological sample taken from the patient.
- The device description focuses on image acquisition and reconstruction. It describes how radiographic images are captured and processed to create tomographic slices. This is characteristic of medical imaging devices, not IVDs.
- The intended use is for dental implant planning and locating impacted teeth. These are clinical applications based on anatomical imaging, not diagnostic tests performed on biological samples.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Volumetric Tomography is intended to be used for producing cross-sectional (tomographic) radiographic images from the edentulous or dentate area of the jaws. The cross-sectional images provide dimensional information for dental implant planning and information about location of impacted teeth.
Product codes (comma separated list FDA assigned to the subject device)
MUH, OAS
Device Description
The Volumetric Tomography imaging option for Orthopantomograph® OP100 and OP200 product families utilizes Statistical Inversion (SI) that is used to reconstruct tomographic images from a set of pre-acquired projection radiographic images of the object. To reconstruct means producing cross-sectional images from a set of projection images by using computer calculation. Projection image means a radiographic image from a certain angle in which the structures of the object are seen superimposed. Tomographic means viewing an object as a series of thin slices.
Projection images are captured with a digital panoramic unit using scanning as the imaging method. Scanning projection images is previously known technique and commonly used for example in digital cephalometric units. Along with the object a set of fiducials are recorded on the projection images to be used for geometry refinement and cross-registration between the reconstructed image set and a separate panoramic scout image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
edentulous or dentate area of the jaws
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "INSTRUMENTARIUM" in a simple, sans-serif font. To the left of the word is a stylized logo. The logo appears to be a lowercase "i" inside of a circle. The logo and the word are both in black.
-1
K063773
page 1 of 3
JAN $ 1 7007
510(k) Summary
Date
December 15, 2006
Manufacturer
Instrumentarium Dental, PaloDEx Group Oy P.O.Box 20 (Street address: Nahkelantie 160) FIN-04301 Tuusula, Finland
Tel: +358 45 7882 2000 Fax: +358 45 7882 2506
Contact person: Mr. Jouni Onnela, Tel +358 40 747 2550
United States Sales Representative (U.S. Designated agent)
INSTRUMENTARIUM DENTAL INC. 300 West Edgerton Ave. Milwaukee, WI 53207 -6025 Tel: +1 414 747 1030, 800 558 6120 Fax: +1 414 481 8665
Contact Person: Mr. Frank Kashinski, Tel +1 414 747 6315
Trade name:
Volumetric Tomography
Common name:
Film/digital dental panoramic X-ray equipment with cephalostat.
Classification name:
Extraoral source X-ray system (21 CFR 872.1800, product code EHD)
Description:
The Volumetric Tomography imaging option for Orthopantomograph® OP100 and OP200 product families utilizes Statistical Inversion (SI) that is used to reconstruct tomographic images from a set of pre-acquired projection radiographic images of the object. To reconstruct means producing cross-sectional images from a set of projection images by using computer calculation. Projection image means a radiographic image from a certain angle in which the structures of the object are seen superimposed. Tomographic means viewing an object as a series of thin slices.
Projection images are captured with a digital panoramic unit using scanning as the imaging method. Scanning projection images is previously known technique and commonly used for example in digital cephalometric units. Along with the object a set of fiducials are recorded on the projection images to be used for geometry refinement and cross-registration between the reconstructed image set and a separate panoramic scout image.
Instrumentarium Dental
| Street address: | Nahkelantie 160, 04300 Tuusula Finland |
|---|---|
| Postal address: | P.O. Box 20, FI-04301 Tuusula, Finland |
| Tel. | +358 45 7882 2000 |
| Fax | +358 45 7882 2506 |
Bank
SWIFT Nordea Bank NDFAFIHH Account: Fl9015963000046864
PaloDEx Group Oy, Tuusula, FINLAND
1
2043773
Page 2 of 3
Tomographic images are then reconstructed from the projection images with a computer. For dimensional information for dental implant planning and information about location of impacted teeth all three imaging modalities can be used: projection image set, the panoramic image and the reconstructed image set. The tomographic slice and the slice angle are selectable after reconstruction to ensure the correct positioning of the slice referenced to the anatomy. In addition to the selection of the tomographic slice also the slice angle is user adjustable to ensure the correct position and angle compared to the anatomy.
When comparing this method to previously known tomographic techniques like continuous linear tomography (such as the OrthoTrans option for OP100 and OP200 film units), the Volumetric Tomography imaging concept can be thought as a discrete tomography in which several slices can be produced from a set of projection images.
The calculation algorithm - Statistical Inversion - is more thoroughly described in the following scientific publications:
Statistical inversion for medical x-ray tomography with few radiographs: I. General theory; Phys. Med. Biol. 48 (2003) 1437-1463 Pli: S0031-9155(03)57800-9
Statistical inversion for medical x-ray tomography with few radiographs: II. Application to dental radiology; Phys. Med. Biol. 48 (2003) 1465-1490 Pli: S0031-9155(03)57801-O
The Volumetric Tomography option comes with a complete image handling software, CliniView, offering the same familiar and intuitive user interface as with the conventional modalities (i.e. Panoramic, cephalometric and intraoral radiographic images). In addition to the Volumetric Tomography specific functionality Cirilifiew features include dynamic zooming, brightness and contrast adjustments, edge enhancement, and measurements. The software runs on Windows 2000 and XP operating systems.
Intended use:
Volumetric Tomography is intended to be used for producing cross-sectional (tomographic) radiographic images from the edentulous or dentate area of the jaws. The cross-sectional images provide dimensional information for dental implant planning and information about location of impacted teeth.
Instrumentarium Dental
Street address: Postal address: ابع آ -3x
Nahkelantie 160, 04300 Tuusula Finland P.O. Box 20, FI-04301 Tuusula, Finland +358 45 7882 2000 +358 45 7882 2506
Bank
SWIFT Nordea Bank NDEAFIHH Account: Fl9015963000046864
2
Image /page/2/Picture/0 description: The image shows the word "INSTRUMENTARIUM" in all capital letters. To the left of the word is a logo that appears to be the letter "i" inside of a circle. The logo and the word are both in black. The background of the image is white.
K063773
Page 36
Substantial Equivalence:
We consider Volumetric Tomography is similar in design, composition and function to the following predicate device introduced into commercial distribution after May 28, 1976:
Orthopantomograph® OP100/Orthoceph® OC100 with OrthoTrans linear tomography option #K973642.
The comparison of characteristics supports substantial equivalence.
Instrumentarium Dental
Street address: Postal address: Tel. Fax
Nahkelantie 160, 04300 Tuusula Finland P.O. Box 20, FI-04301 Tuusula, Finland +358 45 7882 2000 +358 45 7882 2506
Bank
SWIFT Nordea Bank NDEAFIHH Account: F19015963000046864
PaloDEx Group Oy, Tuusula, FiNLAND
3
Image /page/3/Picture/2 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 stylized caduceus or a representation of the human form. The symbol consists of three curved lines that appear to be interconnected.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 2007
Instrumentarium Dental, PaloDEx Group OY % Mr. Frank Kashinski Official Correspondent Instrumentarium Dental, Inc. 300 West Edgerton Ave. MILWAUKEE WI 53207-6025
Re: K063773
Trade/Device Name: Volumetric Tomography Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH and OAS Dated: December 15, 2006 Received: December 21, 2006
Dear Mr. Kashinski:
This letter corrects our substantially equivalent letter of January 31, 2007.
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 (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 (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
4
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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.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 -
5
Indications for Use
510(k) Number (if known): _ C o 63773
Device Name: Volumetric Tomography
Indications for Use:
Volumetric Tomography is intended to be used for producing crosssectional (tomographic) radiographic images from the edentulous or dentate area of the jaws. The cross-sectional images provide dimensional information for dental implant planning and information about location of impacted teeth.
Prescription Use Prescription Ose _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdom and Radiological Devices 510(k) Number __