The ScanX Swift 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

The ScanX Swift View 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

Device Description

The ScanX Swift 2.0 and ScanX Swift View 2.0 are dental devices that scan photostimulable phosphor storage plates that have been exposed in place of dental X- Ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out all cleared plates of the sizes 0, 1, 2, 3, and 4. The phosphor plates are made of rigid photostimulable material. Intraoral phosphor plate x-ray (also known as phosphor storage plate or PSP x-ray) eliminates the need for traditional film processing for dental radiography. Phosphor storage plates can convert existing film based imaging systems to a digital format that can be integrated into a computer or network system. The intraoral Plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with a 639nm Laser. The laser beam is moved across the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of x-ray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via an Ethernet link to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he has to use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection cover and starts the read out process. After the read out process the picture is transmitted to the connected PC, the picture can be viewed and the IP is erased and ready to use for the next acquisition. The main difference between the two models is on the ScanX Swift View 2.0 the display is larger, has touch capability, and can show a preview of the scan image. The device firmware is based on the predicate firmware and is of a moderate level of concern.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (ScanX Swift 2.0, ScanX Swift View 2.0), which focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria for a specific clinical endpoint or a study proving a device meets such criteria.

Instead, it discusses the technological characteristics, safety, and performance of the device in comparison to a predicate device based on non-clinical testing and engineering principles. The document explicitly states:

"Summary of clinical performance testing: Not required to establish substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor details about sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

However, I can extract information related to non-clinical performance testing and technical characteristics, which are used to establish substantial equivalence.

Here's an analysis based on the available information:

Key Takeaways from the Document:

Device Type: Phosphor Storage Plate (PSP) scanner for dental X-ray images.
Purpose: Scan exposed PSPs, process digital images, and display/store them.
Approval Basis: Substantial equivalence to a predicate device (ScanX Edge K202633).
No Clinical Study: Clinical performance testing was explicitly stated as "Not required to establish substantial equivalence." This means the FDA cleared the device based on non-clinical data and comparison to a legally marketed predicate.

Information Related to Device Performance and Equivalence (Non-Clinical):

The document compares the subject devices (ScanX Swift 2.0, ScanX Swift View 2.0) to the predicate device (ScanX Edge) based on various technical specifications and non-clinical performance metrics.

1. Table of "Acceptance Criteria" (Technical Specification Comparison) and Reported Device Performance (as listed for the subject devices):

Since no acceptance criteria are explicitly stated as pass/fail for a clinical endpoint, I will present the comparative technical specifications as the basis for demonstrating equivalence and "performance" in this context. The "acceptance criteria" here are effectively the predicate device's performance, and the subject device's performance is compared against it for substantial equivalence.

Characteristic	Predicate Device (ScanX Edge) "Acceptance Criteria" (for equivalence)	Subject Devices (ScanX Swift 2.0, ScanX Swift View 2.0) Reported Performance	Comparison / Impact Analysis
Max. theoretical resolution	Approx. 40 Lp/mm	Approx. 40 Lp/mm	SAME
MTF (at 3 LP/mm)	More than 40%	Horizontal 59%, Vertical 49% (in 12.5µm pixel size mode)	Similar/better. (Subject device performance is higher than the predicate's stated 'more than 40%')
DQE (at 3 LP/mm)	More than 3.4%	Horizontal 8.5%, Vertical 10.5% (in 12.5µm pixel size mode with 99µGy)	Similar/better. (Subject device performance is significantly higher than the predicate's stated 'more than 3.4%')
Image bit depth	16 bits	16 bits	Identical
Operating Principle	Laser / Photomultiplier Tube (PMT) Components: Photomultiplier 2" Diode, Laser 639nm/10mW Fiber coupled laser diode	Laser / Photomultiplier Tube (PMT) Components: Photomultiplier 2" Diode, Laser 639nm/10mW Fiber coupled laser diode	Identical. Note: While the components are identical, a new "Flying-Spot configuration (PCS technology)" is used, which was cleared in a predecessor device (K170733), suggesting equivalence in efficacy despite a change in the exact scanning mechanism.
Supported Plate Sizes	Size 0 (22x35mm), 1 (24x40mm), 2 (31x41mm)	Size 0, 1, 2, 3 (27x54mm), 4 (57x76mm)	Similar. The predicate device uses smaller phosphor plates: Size 0, 1 and 2. The subject devices support these and add Size 3 and 4, which were available on a previous model (K170733), implying this expansion is also a previously cleared technology. This is presented as an enhancement rather than a deviation that would impact safety/effectiveness negatively.
Data Transfer	Ethernet link	Ethernet link (all models); WLAN interface or removable storage (XPS07.2A1 only)	Similar. The View model offers additional flexibility. Risks associated with WLAN would be addressed by standards compliance (e.g., IEC 60601-1-2 and "Radio Frequency Wireless Technology in Medical Devices" guidance).
Image Generation	Image assembled by imaging software (e.g., VisionX)	Image assembled within the image plate scanner (using same algorithm as K192743)	New. The raw image data is the same, and the algorithm used is the same as already cleared for the VisionX imaging software (K192743), suggesting this change does not impact safety or effectiveness.

2. Sample size used for the test set and the data provenance:

Not explicitly stated for performance testing. The document refers to non-clinical performance testing (MTF, DQE, noise power spectrum) in accordance with IEC 6220-1:2003, which would involve imaging phantoms or test objects.
Data Provenance: Not specified, but given the manufacturer is German (DURR DENTAL SE), the non-clinical testing likely occurred in a controlled lab environment, presumably in Germany or where their R&D facilities are located. These tests are inherently "prospective" in the sense that they are conducted to characterize the specific device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts for clinical studies:

Not applicable. The submission states no clinical performance testing was required. For non-clinical tests like MTF/DQE, ground truth is established by the design of the test phantom and the known physical properties being measured.

4. Adjudication method for the test set (for clinical studies):

Not applicable. No clinical studies were performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. The document explicitly states: "Summary of clinical performance testing: Not required to establish substantial equivalence." Therefore, no MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone imaging acquisition and processing system. The performance metrics (MTF, DQE) are inherently standalone measurements of the device's image quality output.
The ScanX Swift View 2.0 model has a "Stand-Alone-Mode" where it can operate without a connection to a computer, generate image data, and store it on a USB stick. This is a functional feature, not a separate performance study.

7. The type of ground truth used:

For the non-clinical image quality performance metrics (MTF, DQE, noise power spectrum), the ground truth is established by physical standards and phantoms as defined by the IEC 6220-1:2003 standard. These involve known patterns and controlled radiation exposures to objectively measure the imaging system's capabilities.

8. The sample size for the training set:

Not applicable. As this is a 510(k) for a hardware device (PSP scanner) and not an AI/ML algorithm requiring a training set in the typical sense, there is no mention of a "training set" for image processing algorithms. The image processing algorithms used within the device are stated to be "the same as cleared in K192743 for the imaging software VisionX," implying they are established and validated algorithms, not newly trained ones for this specific device.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set discussed for this device submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 6, 2023

Durr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K230095

Trade/Device Name: ScanX Swift 2.0, ScanX Swift View 2.0 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: January 9, 2023 Received: January 12, 2023

Dear Mr. Kamm:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 or any Federal

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang
2023.02.06
16:03:19
-05'00'

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230095

Device Name ScanX Swift 2.0, ScanX Swift View 2.0

Indications for Use (Describe)

The ScanX Swift 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

The ScanX Swift View 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary, DURR DENTAL SE K230095

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Date Summary Prepared: January 25, 2023 1. Submitter's Identification:

DURR DENTAL SE Höpfigheimer Strasse 17 74321 Bietigheim-Bissingen Deutschland/Germany Tel: +49 (0) 71 42 70 5-0 Fax: +49 (0) 71 42 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com

Submitter Contact: Mr. Oliver Lange Director of Quality Management DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen, Germany Phone: + 49 (0) 7142 70 5-190 Email: oliver.lange@duerrdental.com

U.S. Agent and Contact: Mr. Joseph Latkowski Director of Quality and Regulatory Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747, USA U.S. Phone: 516-214-5574 E-Mail: Joseph.Latkowski@airtechniques.com

1. Device Name:

Trade /Proprietary Name:	ScanX Swift 2.0, ScanX Swift View 2.0
Regulation Number:	21 CFR 872.1800
Regulation Name:	Extraoral source x-ray system
Regulatory Class:	II
Product Code:	MUH

Legally Marketed Predicate Device Information:

Trade/Device Name:	K202633, ScanX Edge
Regulation Number:	21 CFR 872.1800
Regulation Name:	Extraoral source x-ray system
Regulatory Class:	II
Product Code:	MUH

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4. Device Description:

Indications for use: (Identical for two models, same as predicate) The ScanX Swift 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications. The ScanX Swift View 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

1. Summary of the technological characteristics of the device compared to the predicate device: The ScanX Swift 2.0 / ScanX Swift View 2.0 is a device that scans photostimulable phosphor storage plates that have been exposed in place of x-ray film and allows the resulting images to be displayed on a personal computer monitor. Safety concerns associated with the ScanX Swift View 2.0 were addressed by safety testing the device according to recognized consensus standards as listed in the section below: "List of Applied Standards". Design changes and risks associated with the introduction of the ScanX Swift View 2.0 were properly mitigated by DURR DENTAL SE's cGMP compliant Quality Management System, change control processes, risk assessments, and product validation. The ScanX Swift View 2.0 contains a Class 1 Laser Device as defined by 21 CFR 1040.10. The modified units employ RFID in the same manner as the predicate. Installation and operation manuals are provided with instructions for safe use and servicing of the ScanX Swift 2.0 / ScanX Swift View 2.0. The ScanX Swift View 2.0 is a non-patient contact Class II medical device.
1. Equivalence to Predicate Device Summary:

DURR DENTAL SE's ScanX Swift 2.0 / ScanX Swift View 2.0 units are identical in function, and intended use to the DURR DENTAL SE ScanX Edge K202633. All three units capture, digitize, and process intraoral x-ray images that are stored in imaging plate recording media. The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Both units have the convenience of RFID capability. The main difference is the addition of compatible plate sizes: Size 3: 27 x 54 mm and Size 4: 57 x 76 mm. Refer to the substantial equivalence comparison table below..

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Device	Predicate device	Subject devices	Subject devices	Change ImpactAnalysis
Trade name	ScanX Edge	ScanX Swift 2.0	ScanX Swift View 2.0	---
Model Name	ScanX Edge	XPS07.1A1	XPS07.2A1	---
Clearance	K202633	---	---	---
Device Picture	Image: ScanX Edge	Image: ScanX Swift 2.0	Image: ScanX Swift View 2.0	Different.
Indications forUse	The ScanX Edge is intended to beused for scanning and processingdigital images exposed on PhosphorStorage Plates (PSPs) in dentalapplications.	The ScanX Swift 2.0 is intended tobe used for scanning andprocessing digital images exposedon Phosphor Storage Plates (PSPs)in dental applications.	The ScanX Swift View 2.0 is intendedto be used for scanning andprocessing digital images exposed onPhosphor Storage Plates (PSPs) indental applications.	Identical.
Operatingprinciple	The PSPs are put into the mouth of thepatient, exposed to X-rays, and thenare read out with the device. The read-out-process is carried out with a 639nm Laser. The laser beam stimulatesthe top coating of the plates, whichconsists of x-ray sensitive material.Depending on the exposed dose, thecoating emits different levels of light.These light particles are thenrequisitioned by an optical sensor andtransferred into an electrical outputsignal. This signal is digitalized and isthe data for the digital X-ray image.	The PSPs are put into the mouth of the patient, exposed to X-rays, andthen are read out with the device. The read-out-process is carried outwith a 639 nm Laser. The laser beam stimulates the top coating of theplates, which consists of x-ray sensitive material. Depending on theexposed dose, the coating emits different levels of light. These lightparticles are then requisitioned by an optical sensor and transferred intoan electrical output signal. This signal is digitalized and is the data for thedigital X-ray image.		Identical.
		Technical equivalence:
Device	Predicate device	Subject devices	Change ImpactAnalysis
Data transfer	The data is transmitted via anEthernet link.	The data is transmitted via an Ethernet link to a computer. With theXPS07.2A1 the data can alternatively be transferred by a WLANinterface or being stored on a removeable storage medium.	Similar.
Erasing theresidual imagefollowingscanning forplate reuse	After the scanning process, theremaining data is erased by a LEDlight.	After the scanning process, the remaining data is erased by a LEDlight.	Identical.
Display	The ScanX Edge does not have ascreen / display.The device state is indicated viastatus LEDs lights on the device.	2.4"-DisplayThe display does not showpreview images.5"-Touch Display: The touchscreen only shows a previewwhich serves to provide an initialimpression of the final x-rayimage. For the purposes ofdiagnosis, the x-ray image must beviewed on a diagnostic PCmonitor.Diagnostic monitor = PC monitor.The scanner itself is not used fordiagnosis.	Similar.
Imaging scanning	Laser / Photomultiplier Tube (PMT)Components:Photomultiplier 2"Diode, Laser 639nm/10mW Fibercoupled laser diode	Laser / Photomultiplier Tube (PMT)Components: Photomultiplier 2"Diode, Laser 639nm/10mW Fiber coupled laser diode	Identical.
Plate guide	A specific plate guide for each PSPsize is available, thus the userchooses which size of PSP he wantsto use and prepares the device byinserting the appropriate plate guideinto the device.	A specific plate guide for each PSP size is available, thus the user chooseswhich size of PSP he wants to use and prepares the device by inserting theappropriate plate guide into the device.	Identical.
Device	Predicate device	Subject devices	Change ImpactAnalysis
Transport / feedmechanism	The plates are inserted into a sizespecific interchangeable insert. Ifthe user wants to scan a differentplate size, the insert needs to beexchanged. The insert is used totransport the plate into thescanning position. During thescanning process the plate is notmove. Upon completion of thescanning.	The plates are inserted into a size specific interchangeable plateguide. If the user wants to scan a different plate size, the plate guideneeds to be exchanged.The plate is transported beltway down the axis of the cylinder pastthe slot. The motion of the laser and plates provides the twoorthogonal scan directions. This is a continuous feed device thatallows successive plates to be loaded as soon as the previous plateshave moved past the slot.	Similar.The solutions forthe plate guideshave evolved forScanX Swift 2.0and ScanX SwiftView 2.0. Thefeed andtransport areequivalent.
WLAN (Wi-Fi)	No	Yes	Different. Addedinterfaceflexibility
Ethernet	Yes	Yes	SAME
RFID	Supports image plates with RFIDTags. The information on the RFIDtag is used to identify the imageplate.	Supports image plates with RFIDTags. The information on theRFID tag is used to identify theimage plate.	Identical.The RFID imageplates areidentical.
Device	Predicate device	Subject devices	Change ImpactAnalysis
Operation /Function	The image plate scanner is usedto read image data stored on animage plate and to transfer thedata to the imaging software (e.g.VisionX) on a computer.The transport mechanism guidesthe image plate through thedevice. The image plate is readusing a laser inside the scannerunit. The scanned datais converted into a digital imageand transferred to the imagingsoftware.After scanning, the image plateruns through the erasure unit.Image data still held on the imageplate is erased with the aid ofbright light.The image plate is then ejectedfor re-use.	The phosphor storage platescanner is used to scan image datastored on a phosphor storage plateand transfer the data to theimaging software (e.g. VisionX) ona computer.The transport mechanism guidesthe phosphor storage platethrough the device. The phosphorstorage plate is read using a laserinside the scanner unit. Thescanned data is converted into adigital image and transferred tothe imaging software.After scanning, the phosphorstorage plate runs through theerasure unit. Image data still heldon the phosphor storage plate iserased with the aid of bright light.The phosphor storage plate is thenejected for re-use.	The phosphor storage plate scanneris used to read image data stored onthe phosphor storage plate. The unitcan be used in two different ways: viathe imaging software (e. g. VisionX)on a PC or directly via the touchscreen on the unit.The transport mechanism guides thephosphor storage plate through thedevice. A laser in the scanner unitscans the PSP. The scanned data isconverted into a digital image.If a scanning job is started via theimaging software, the image isautomatically transmitted to thecomputer. If a scanning job is startedvia the touch screen, the image issaved to the memory card and needsto be transferred to the computerlater on. After scanning, thephosphor storage plate runs throughthe erasure unit. Image data still heldon the phosphor storage plate iserased with the aid of bright light.The phosphor storage plate is thenejected for re-use.	Identical.Different:ScanX Swift View2.0:The touch screenallows the unit tobe operated in astand-alonemode (without aconnection to acomputer). Thedevice is able togenerate theimage data itselfand to store it ona data medium(USB stick).Instructions canbe entered onthe touch screenwith the tip of afinger.
Phosphorstorage plates	Only AT Phosphor Storage Plateswith RFID tag:Size 0: 22 x 35 mmSize 1: 24 x 40 mmSize 2: 31 x 41 mm	Only AT Phosphor Storage Plates with RFID tag:Size 0: 22 x 35 mmSize 1: 24 x 40 mmSize 2: 31 x 41 mmSize 3: 27 x 54 mmSize 4: 57 x 76 mm	Similar. Thepredicate deviceuses the smallerphosphor plates:Size 0, 1 and 2.
Device	Predicate device	Subject devices		Change ImpactAnalysis
Max. theoreticalresolution(Line pairs/mm)	Approx. 40 Lp/mm	Approx. 40 Lp/mm		SAME.
MTF	More than 40% at 3 LP/mm	Horizontal 59% Vertical 49% at 3LP/mm in 12.5µm pixel size mode		Similar/better.
DQE	More than 3,4% at 3 LP/mm	Horizontal 8.5%, Vertical 10.5% at 3LP/mm in 12.5µm pixel size mode withan exposure of 99µGy		Similar/better.
Image bit depth	16 bits	16 bits	16 bits	Identical.
Dimensions (mm)(W x H x D)	167 x 244 x 216	211 x 249 x 258	211 x 273 x 258	Different.
Weight	Approx. 4 kg(8,82 lb)	Approx. 5,1 kg(11,24 lb)	Approx. 5,3 kg(11,68 lb)	Different.
Energy SourceAC	100 to 240VAC, 50/60 Hz	100 to 240VAC, 50/60 Hz	100 to 240VAC, 50/60 Hz	Identical.
ImagingSoftware	• DBSWIN (K203287)• VisionX (K213326)	• VisionX (K213326)	• VisionX (K213326)	Different.The predicate canbe used withDBSWIN or VisionXimaging software,whereas thesubject devicesexclusively usedwith the VisionXimaging software.
PatientContaminationPrevention	Single patient use barrier envelopeencloses the imaging plate while inthe patient's mouth.	Single patient use barrier envelopeencloses the imaging plate while inthe patient's mouth.	Single patient use barrier envelopeencloses the imaging plate while inthe patient's mouth.	Identical.
AdditionalFeatures	None.	• Flip-side detection	• Stand-Alone-Mode• Flip-side detection• SmartScan Workflow:ScanX Smart Reader	Different. TheScanX SmartReader is a newaccessory which isincluded in thescope of delivery ofthe subject deviceScanX Swift View2.0.

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Discussion of Similarities and Differences:

1) Interface between the subject devices and the imaging software (VisionX):

New: The image generation originates on the image plate scanner side of the software interface. Previously the image was assembled by the imaging software (e.g. VisionX). As a novelty, the composition of the image now takes place within the image plate scanner. The raw image data used to assemble the image is the same. The algorithm used for this process is the same as cleared in K192743 for the imaging software VisionX.

2) Smart Scan Workflow:

The ScanX Smart Reader is a new accessory which is included in the scope of delivery of the subject device ScanX Swift View 2.0. The ScanX Smart Reader is not a medical device. The unit is able to read RFID chips from different sources. Using the ScanX Smart Reader it is possible to assign IQ image plates to a patient. The images are then automatically assigned to this patient when they are scanned.

3) Stand-Alone Modus:

ScanX Swift View 2.0: The touch screen allows the unit to be operated in a stand-alone modus, without a connection to a computer. The device is able to generate the image data itself and to store it on a data medium (USB stick). Instructions can be entered on the touch screen with the tip of a finger.

4) Wifi

Applicable for ScanX Swift View 2.0 only. All models support Ethernet connection to the host computer.

5) Display/ Screen:

The subject devices have displays. The ScanX Swift View 2.0 does have a touch screen, which allows the unit to be operated in a stand-alone modus. The predicate device ScanX Edge does not have a screen. This difference does not influence the intended use for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

6) Technology:

The feeding and scanning process are different.

The predicate device ScanX Edge uses the MEMS technology: MEMS = Micro Electro Mechanical Systems.
The subject devices ScanX Swift 2.0 and ScanX Swift View 2.0 use the Flying-Spot configuration (PCS technology): PCS = Photo Collecting Systems. This technology was already cleared for a predecessor device ScanX Intraoral View (IO View), in K170733.

7) Image Plate Sizes:

The modified ScanX models allow the use of previously cleared larger plate sizes. These larger sizes were available on our previous model ScanX cleared in K170733.
The technological characteristics, including design, materials, composition, and energy source, are essentially the same, so there are no issues impacting safety and effectiveness.

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1. Summary of non-clinical performance testing:
  Risk analysis and software validation was successfully performed. Cybersecurity issues were addressed by observance of the recommendations in the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Druq Administration Staff The following FDA guidance documents were consulted during the development of this device:

FDA Guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications" FDA Guidance "Radio Frequency Wireless Technology in Medical Devices."

FDA Guidance "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices,.

This device meets the applicable portions of the following international standards:

IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014, (Professional healthcare facility environment / Emission class B) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

IEC-60825-1 Safety of laser products - Part 1: Equipment classification and requirements Ed.2. The laser aspects of this device comply with the US Performance Radiation Safety Standard in 21CFR1040.

MTF, DQE, and image resolution performance testing was performed in accordance with IEC 6220-1:2003. The results were measured values, not theoretical. Noise power spectrum measurements were documented. The following FDA Guidance Document was consulted during the development of this device: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for Industry and Food and Drug Administration Staff,

The development of labeling was done in accordance with the FDA Guidance Pediatric Information for Xray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff. Because the modified unit employs RFID, we also consulted the FDA Guidance Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff.

1. Summary of clinical performance testing: Not required to establish substantial equivalence.
1. Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, DÜRR Dental SE concludes that the ScanX Swift 2.0, ScanX Swift View 2.0 models are safe and effective and substantially equivalent to the predicate device as described herein.

Regulation Number and Section

§ 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.