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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Scanora 3D device:

Acceptance Criteria and Device Performance

The submission primarily focuses on establishing "substantial equivalence" to predicate devices rather than defining explicit performance acceptance criteria with numerical thresholds. The acceptance is based on demonstrating that the new Scanora 3D device is as safe and effective as existing legally marketed devices.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Technological Characteristics (comparable to predicates)	- X-ray source: 3D mode: 90 kV, 4-12.5 mA, pulsed; Pan mode: 60-81 kV, 4-8 mA continuous; kV accuracy +/-5kV.- Focal spot: 0.5 mm.- Image detector(s): CMOS Flat Panel + CCD for panoramic imaging.- 3D imaging technique: Reconstruction from 2D images.- 3D's Field Of View: H60 x Ø60 mm, H75 x Ø100 mm, H75 x Ø145 mm, H130xØ145 mm – stitched.- 3D's total viewing angle: 360 degrees.- Pixel size: CMOS Flat panel: 200 µm; CCD for panoramic imaging: 48 µm.- Voxel size: 133/200/250/300/350 µm.- 3D scan time: 10 - 26 sec.- 3D's effective exposure time: 2.25 - 6 sec.
Indications for Use (similar to predicates)	- Scanora 3D: 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. Device operated by qualified healthcare professionals.
Safety and Effectiveness (demonstrated via substantial equivalence)	- "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."
Image Quality (comparable to predicates)	- "Bench test image quality comparison between the Scanora 3D and the predicate devices was performed." (Specific metrics or quantitative comparisons are not provided in the summary.)
Software Validation (successful)	- "The Scanora 3D software has been successfully validated to confirm the performance of this device."

Study Details

The provided document describes a non-clinical study to demonstrate substantial equivalence, rather than a clinical trial with specific performance metrics against an acceptance criterion.

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a number of images or cases. The study involved a "Bench test image quality comparison." This typically involves phantom images or controlled test objects, not patient data in the context of this submission.
- Data provenance: Not explicitly stated. Given it's a bench test, the data would originate from the testing environment (e.g., phantom images generated by the device). It is not specified as retrospective or prospective clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. Since the study was a "bench test image quality comparison," it's unlikely that clinical experts were used to establish ground truth in the traditional sense for diagnostic accuracy. Ground truth for bench tests typically involves known physical properties of phantoms or objective measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None specified. This type of adjudication is typically used in clinical studies involving interpretation of images by multiple readers, which was not described as part of this submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing has not been conducted on this device." This device is an imaging system, not an AI-assisted diagnostic tool, so "human readers improve with AI vs without AI assistance" is not applicable to this submission. The focus is on the imaging system's inherent capabilities.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- A standalone performance evaluation was done. The "Bench test image quality comparison" evaluates the device itself (hardware and reconstruction software) without human diagnostic interpretation being the primary endpoint of the substantial equivalence claim. The "successful validation of the Scanora 3D software" also represents a standalone assessment of the software's functionality.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Bench test image quality comparison," the ground truth would likely be based on known physical characteristics of test phantoms or objective measurements pertinent to image quality (e.g., resolution, contrast, noise, geometric accuracy). It is not expert consensus, pathology, or outcomes data, as these are related to clinical diagnostic accuracy, which was not assessed in this submission.
The sample size for the training set:
- This information is not applicable/not provided in the context of this submission. This device is an imaging hardware system with reconstruction software. It does not describe an AI model that requires a "training set" in the machine learning sense. The "software validation" refers to confirming that the device's operational software (e.g., for image acquisition, reconstruction, and basic processing) functions as intended and meets specifications, not training a diagnostic algorithm.
How the ground truth for the training set was established:
- This information is not applicable/not provided for the reasons stated above (not an AI training set).

Summary

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ARRETTING OUR BELLERS FOR

510(k) Summary

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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:

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 mmH75 x Ø100 mmH75 x Ø145 mmH130xØ145 mm – stitched	H60 x Ø60 mmH75 x Ø100 mmH75 x Ø145 mm	H40 x Ø40 mmH60 x Ø60 mmH80 x Ø80 mmH100 x Ø100 mmH120 x Ø170 mm
6.	3D's total viewing angle	360 degrees	360 degrees	180/360 degrees
7.	Pixel size	CMOS Flat panel: 200 µmCCD for panoramic imaging: 48 µm	CMOS Flat panel: 200 µmCCD 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 Beam3D x-ray system for imagingthe head and neck areas,including the ENT anddentomaxillofacial areas, foruse in diagnostic support.Dedicated panoramicimaging is an option. A flatpanel detector is used toacquire 3D images and anoptional CCD sensor toacquire panoramic images.The device is operated andused by qualified healthcareprofessionals.	Scanora 3D is a dentalcone beam computedtomography x-raysystem intended toimage teeth, jaw andTMJ areas of the skull.A flat panel detector isused to acquire 3Dimages and an optionalCCD sensor to acquirepanoramic images. Thedevice is operated andused by dentists andother qualifiedprofessionals.	The Model MCT-1EX-1F8/F17 is an x-rayimaging device thatacquires a 360 degreerotational sequence ofthe head and neck areas,including the ENT anddentomaxillofacial areas,for use in diagnosticsupport. The deviceaccomplishes this task byreconstructing a threedimensional matrix ofthe examined volumeand producing twodimensional views of thisvolume, displaying bothtwo and threedimensional images.The device is operatedand used by physicians,dentists and x-raytechnologists.
12.	System footprint	H197cm xD140cm xW160cm	H197cm xD140cm xW160cm	H208cm x D120cm xW162cm
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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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

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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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SOREDEX

Indications for Use

510(k) Number (if known):

Device Name: _Scanora 3D

Indications for Use:

× 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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Regulation Number and Section

§ 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.