(97 days)
Not Found
No
The summary describes a standard medical imaging device and its reconstruction software, with no mention of AI or ML capabilities for image analysis, interpretation, or other functions.
No.
The device is used for diagnostic imaging, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "for use in diagnostic support," indicating its role in the diagnostic process.
No
The device description explicitly states it is a "Cone beam 3D x-ray system" and mentions hardware components like a "flat panel detector" and an "optional CCD sensor" for image acquisition. While it uses 3rd party software for reconstruction and viewing, the core device is a hardware-based imaging system.
Based on the provided information, the Scanora 3D device is not an IVD (In Vitro Diagnostic).
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.
- Scanora 3D Function: The Scanora 3D is an imaging system that uses X-rays to create images of the head and neck. It directly images the patient's anatomy rather than analyzing samples taken from the patient.
The description clearly states it's an "x-ray system for imaging the head and neck areas" and that it "directly images the patient's anatomy". This aligns with the definition of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Scanora 3D is a Cone Beam 3D X-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. 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 qualified healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
MUH, JAK, OAS
Device Description
Scanora 3D is a Cone beam 3D x-ray system for Dentomaxillofacial and Head & Neck (ENT) imaging. Dedicated panoramic imaging is an option. In CT mode it generates a conical x-ray beam during rotation around a patient's head and produces two dimensional projection images on a flat panel detector. Three dimensional images are then reconstructed and viewed with 3rd party software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dentomaxillofacial complex and the head and neck areas, including the ear, nose and throat (ENT) areas of the human skull.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare 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)
Bench test image quality comparison between the Scanora 3D and the predicate devices was performed.
The Scanora 3D software has been successfully validated to confirm the performance of this device.
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.
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ARRETTING OUR BELLERS FOR
510(k) Summary
Image /page/0/Picture/2 description: The image shows a line graph. The line is mostly straight, with a slight curve in the middle. The line is solid and black. There are some dashed lines below the solid line.
Date:
MARES 2017
22 March 2011
Recomment
JUN 3 0 2011
110839
Manufacturer:
SOREDEX, PaloDEx Group Oy P.O.Box 148 (Street address: Nahkelantie 160) FIN-04301 Tuusula, Finland
Tel: +358 10 270 2000 Fax: +358 9 851 4048
Contact person: Mr. Matti Tulikoura, Tel +358 400 609 507
United States Sales Representative (U.S. Designated agent):
1245 W. Canal St. Milwaukee, WI 53233 U.S.A. Tel. +1 (414) 747-1030 , +1 (800) 558-6120 Fax +1 (414) 481-8665
Contact Person: Mr. Frank Kashinski, Tel +1 414 747 6315
Trade Name: Scanora 3D
Common Name:
Cone beam 3D X-ray system
Classification Name:
Extraoral source X-ray system (21 CFR 872.1800, product code MUH) Computed tomography x-ray system (21 CFR 892.1750, product code JAK)
Description:
Scanora 3D is a Cone beam 3D x-ray system for Dentomaxillofacial and Head & Neck (ENT) imaging. Dedicated panoramic imaging is an option. In CT mode it generates a conical x-ray beam during rotation around a patient's head and produces two dimensional projection images on a flat panel detector. Three dimensional images are then reconstructed and viewed with 3rd party software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.
SOREDEX PaloDEx Group Oy Nahkelantie 160 P.O.Box 148 -04301 Tuusula. Finland 1 +358 10 270 2000 Fax + 358 9 701 5261 Info@soredex.com www.soredex.com VAT FI 198 10468
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Image /page/1/Picture/1 description: The image shows the word "SOREDEX" in bold, black letters. The first letter, "S", is stylized with a sharp, angular design. The rest of the letters are in a sans-serif font and are evenly spaced. The background is white.
Intended Use:
The unit must only be used and operated by qualified healthcare professionals.
The unit must only be used to take 3D and (OPTIONAL) panoramic images of the dentomaxillofacial complex and the head and neck areas, including the ear, nose and throat (ENT) areas of the human skull. It must not be used to take images of any other part of the human body.
Summary of Technological Characteristics:
Scanora 3D is substantially equivalent in design, composition and function to the current Scanora 3D unit as well as to another unit currently marketed by J. Morita USA, Inc.
| | Concept | SCANORA 3D | SCANORA 3D
(K073350, MUH/JAK) | Morita 3D Accu-I-tomo 170 XYZ Slice view Tomograph (K073695, JAK) |
|-----|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| 1. | x-ray source | 3D mode: 90 kV, 4-12.5 mA, pulsed.
Pan mode: 60-81 kV, 4-8 mA continuous.
kV accuracy +/5kV,
Same x-ray source for 3D and Pan modes. | 3D mode: 85 kV, 8-15 mA, pulsed.
Pan mode: 60-81 kV, 4-8 mA continuous.
kV accuracy +/5kV,
Same x-ray source for 3D and Pan modes. | 60-90 kV, 1-10 mA continuous |
| 2. | Focal spot | 0.5 mm | 0.5 mm | 0.5 mm |
| 3. | Image detector(s) | CMOS Flat Panel + CCD for panoramic imaging | CMOS Flat Panel + CCD for panoramic imaging | Amorphous Silicon Flat Panel |
| 4. | 3D imaging technique | Reconstruction from 2D images | Reconstruction from 2D images | Reconstruction from 2D images |
| 5. | 3D's Field Of View | H60 x Ø60 mm
H75 x Ø100 mm
H75 x Ø145 mm
H130xØ145 mm – stitched | H60 x Ø60 mm
H75 x Ø100 mm
H75 x Ø145 mm | H40 x Ø40 mm
H60 x Ø60 mm
H80 x Ø80 mm
H100 x Ø100 mm
H120 x Ø170 mm |
| 6. | 3D's total viewing angle | 360 degrees | 360 degrees | 180/360 degrees |
| 7. | Pixel size | CMOS Flat panel: 200 µm
CCD for panoramic imaging: 48 µm | CMOS Flat panel: 200 µm
CCD for panoramic imaging: 48 µm | 127 µm |
| 8. | Voxel size | 133/200/250/
300/350 µm | 133/200/250/
300/350 µm | 80/125/160/250 µm |
| 9. | 3D scan time | 10 - 26 sec | 10 - 20 sec | 5.4 - 30.8 sec |
| 10. | 3D's effective exposure time | 2.25 - 6 sec | 2.25 - 4.5 sec | 5.4 - 30.8 sec |
SOREDEX
PaloDEx Group Oy Nahkelantie 160 P.O.Box 148 "-04301 Tuusula, Finland 1 +358 10 270 2000 "Fax + 358 9 701 5261 Info@soredex.com www.soredex.com VAT FI 198 10468
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Image /page/2/Picture/1 description: The image shows the word "SOREDEX" in bold, black letters. The first letter, "S", is stylized with a sharp, angular design on its left side. The remaining letters are in a standard, sans-serif font, creating a strong visual impact. The word appears to be a logo or brand name, presented in a clear and legible manner.
| 11. | Indications for use | Scanora 3D is a Cone Beam
3D x-ray system for imaging
the head and neck areas,
including the ENT and
dentomaxillofacial areas, for
use in diagnostic support.
Dedicated panoramic
imaging is an option. 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 qualified healthcare
professionals. | 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. | The Model MCT-1EX-
1F8/F17 is an x-ray
imaging device that
acquires a 360 degree
rotational sequence of
the head and neck areas,
including the ENT and
dentomaxillofacial areas,
for use in diagnostic
support. The device
accomplishes this task by
reconstructing a three
dimensional matrix of
the examined volume
and producing two
dimensional views of this
volume, displaying both
two and three
dimensional images.
The device is operated
and used by physicians,
dentists and x-ray
technologists. |
|-----|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 12. | System footprint | H197cm x
D140cm x
W160cm | H197cm x
D140cm x
W160cm | H208cm x D120cm x
W162cm |
| 13. | Weight | 310 kg | 310 kg | Approx. 400 kg |
Non-clinical Test Data:
Bench test image quality comparison between the Scanora 3D and the predicate devices was performed.
The Scanora 3D software has been successfully validated to confirm the performance of this device.
Clinical Test Data:
Clinical testing has not been conducted on this device.
Conclusion:
Based upon the similar technological/performance characteristics and image comparison as compared to the predicate devices and successful validation of the Scanora 3D software, the clinical performance of the Scanora 3D is deemed to be substantially equivalent to the predicate devices.
SOREDEX PaloDEx Group Oy Nahkelantie 160 P.O.Box 148 "-04301 Tuusula, Finland 1 +358 10 270 2000 ˜ѓах + 358 9 701 5261 Info@soredex.com www.soredex.com VAT FI 198 10468
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUN 3 0 2011
Mr. Matti Tulikoura Regulatory Manager SOREDEX. PaloDEx Group Oy P.O. Box 148 (Street address: Nahkelantie 160) FIN-04301 Tuusula FINLAND
Re: K110839
Trade/Device Name: Scannora 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: June 23, 2011 Received: June 27, 2011
Dear Mr. Tulikoura:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows a black background with white speckles. In the upper right corner, the words "digital imaging made easy" are written in white letters. The text is slightly blurry and appears to be part of a larger document or presentation.
SOREDEX
Indications for Use
510(k) Number (if known):
Device Name: _Scanora 3D
Indications for Use:
Scanora 3D is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. 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 qualified healthcare professionals.
× Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Spastel
Division Sign Off
Division Sian-6 Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110839
SOREDEX PaloDEx G Nahkelantie Tuc P.O.Box 148 04301 Tuusula, Finland 2000 07 00 858 ﺍﻟﺘ Fax + 358 9 701 5261 Info@soredex.com www.soredex.com VAT FI 198 10468
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