(20 days)
Not Found
No
The summary describes standard image reconstruction software for CT data and does not mention any AI/ML capabilities or related performance metrics.
No
The device is an imaging system used for diagnosis, not for treating a condition.
Yes
The device is described as an "x-ray system intended to image teeth, jaw and TMJ areas of the skull," and it produces "3D images" that are "reconstructed and viewed with software." This imaging capability is used by "dentists and other qualified professionals" to visualize anatomical structures, which is a fundamental aspect of diagnosis. The mention of its use for "imaging" in a clinical setting implies its role in providing information necessary for medical assessment and diagnosis.
No
The device description clearly states it is a dental cone beam computed tomography x-ray system, which includes hardware components like an x-ray generator, detector, and gantry, in addition to software for image reconstruction and viewing.
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 an imaging system that uses X-rays to create images of the teeth, jaw, and skull. It directly images the patient's anatomy, not specimens taken from the patient.
The description clearly states its purpose is to "image teeth, jaw and TMJ areas of the skull" using X-ray technology. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by dentists and other qualified professionals.
Product codes (comma separated list FDA assigned to the subject device)
MUH, JAK
Device Description
Scanora 3D is a dental cone beam CT for imaging of teeth, jaw and TMJ areas of the skull. In CT mode it generates a pulsed conical x-ray beam during rotation around a patient's head and produces two dimensional images on a flat panel detector. Three dimensional images are then reconstructed and viewed with software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (Dental cone beam CT, Panoramic X-ray)
Anatomical Site
teeth, jaw and TMJ areas of the skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and other 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)
A non-clinical image quality comparison demonstrated Scanora 3D produces similar image quality to the predicate device. Scanora 3D complies with applicable FDA and FDA recognized performance standards.
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
§ 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.
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K073350
6-1 Pg 1 of 2
Image /page/0/Picture/1 description: The image shows the word "SOREDEX" in bold, black letters. To the left of the word is a black graphic that is partially obscured. The text is in all caps and appears to be a company logo. The background is white.
510(k) Summarv
Date:
July 23, 2007
Manufacturer:
SOREDEX. PaloDEx Group Ov P.O.Box 148 (Street address: Nahkelantie 160) FIN-04301 Tuusula, Finland
DEC 1 9 2007
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:
Scanora 3D
Common name:
Dental cone beam 3D x-ray system with dedicated panoramic imaging
Classification name:
Extraoral source X-ray system (21 CFR 872.1800, product code MUH)
Description:
Scanora 3D is a dental cone beam CT for imaging of teeth, jaw and TMJ areas of the skull. In CT mode it generates a pulsed conical x-ray beam during rotation around a patient's head and produces two dimensional images on a flat panel detector. Three dimensional images are then reconstructed and viewed with software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.
Intended use:
Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by dentists and other qualified professionals.
SOREDEX PaloDEx Group Oy, Nahkelantie 160 P.O. Box 148, 04301 Tuusula, FINLAND • TEL +358 45 7882 2000 FAX +358 9 701 5261 · info@soredex.com · www.soredex.com · VAT FI19810468
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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a document identifier or page number. The text includes "K073350" at the top, followed by "pg. 2 of 2" and "6.-2" below. The handwriting is somewhat stylized, with distinct letter formations and spacing.
Image /page/1/Picture/1 description: The image shows the word "SOREDEX" in bold, black letters. To the left of the word is a graphic that is also in black. The graphic is abstract and appears to be a stylized letter or symbol.
Substantial Equivalence:
We consider Scanora 3D is similar in design, composition and function to the following predicate devices introduced into commercial distribution after May 28, 1976:
Planmeca Promax 3D (K060328, MUH) i-CAT Scanner (K061284, MUH)
The assesment of characteristics and performance supports substantial equivalence.
Assesment of characteristics and performance:
Scanora 3D has the same technological characteristics as the predicate devices. It has similar x-ray generation, detectors, imaging technique and system footprint to the predicate devices. A non-clinical image quality comparison demonstrated Scanora 3D produces similar image quality to the predicate device. Scanora 3D complies with applicable FDA and FDA recognized performance standards.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SOREDEX, PaloDEx Group Oy % Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K073350
Trade/Device Name: Scanora 3D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: MUH and JAK Dated: November 27, 2007 Received: November 29, 2007
Dear Mr. Lehtonen:
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.
DEC 1 9 2007
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.
3
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/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
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Indications for Use
510(k) Number (if known):
Device Name: Scanora 3D
Indications for Use:
Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. A flat panel detector is nevel to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by dentists and other 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tony M. Whan
on Sian-Off) ivision of Reproductive, Abdominal and adiological Devices
70(k) Number P615350
SOREDEX PaloDEx Group Oy, Nahkelantie 160 P.O. Box 148, 04301 Tuusula, FINLAND • TEL +358 45 7882 2000 FAX +358 9 701 5261 · Info@soredex.com · www.soredex.com · VAT FI19810468