(26 days)
Not Found
No
The description focuses on the hardware and image acquisition process, with no mention of AI or ML algorithms for image processing or analysis.
No.
The device scans and processes images from X-ray exposures, but it does not directly treat or diagnose a condition.
No
Explanation: The device is described as an intraoral Plate Scanner that converts X-ray exposed phosphor plates into digital images for display and storage. Its function is to acquire and process images, not to interpret or diagnose medical conditions directly. The intended use is for "scanning and processing digital images," which is an imaging function, not a diagnostic one.
No
The device description clearly outlines hardware components such as a laser, MEMS mirror, optical sensor (PMT), LED-PCB, and plate inserts, which are integral to the device's function of scanning and processing images from PSPs.
Based on the provided information, the ScanX Edge is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The ScanX Edge processes images from phosphor storage plates that have been exposed to X-rays in the patient's mouth. It is not analyzing biological samples like blood, urine, or tissue.
- The intended use is for scanning and processing dental X-ray images. This is a diagnostic imaging device, not a device used for in vitro testing.
- The device description focuses on the technical aspects of scanning and image processing. It does not mention any analysis of biological markers or substances.
The ScanX Edge falls under the category of a medical imaging device, specifically a dental X-ray image scanner.
N/A
Intended Use / Indications for Use
The ScanX Edge is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
Product codes
MUH
Device Description
The ScanX Edge is a dental device that scans 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 intraoral Plates of the sizes 0, 1 and 2. intraoral plate Scanners are state of the art since 2002 and are available in various designs from many companies around the world. 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 635nm Laser. The laser beam is moved across the surface of 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Phosphor Storage Plates (PSPs) exposed to X-rays
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed clinicians and authorized technicians / dental applications
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
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 Drug Administration Staff Document Issued on: October 2, 2014. This device meets the applicable portions of IEC 60601-1:2005, IEC 60601-1-2:2014, and IEC-60825-1. MTF and DQE image performance testing was performed with reference to IEC 62220-1:2003. 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, Document issued on: September 1, 2016.
Clinical performance testing: Not required to establish substantial equivalence.
Key Metrics
MTF: More than 40% at 3 LP/mm
DQE: More than 3.4% at 3 LP/mm
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
October 7, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Dürr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K202633
Trade/Device Name: ScanX Edge Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: September 1, 2020 Received: September 11, 2020
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 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
1
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 (OS) 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202633
Device Name ScanX Edge
Indications for Use (Describe)
The ScanX Edge 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary, DÜRR DENTAL SE K202633
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: August 14, 2020
-
- Submitter's Identification:
DÜRR 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's Identification:
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
-
- Device Name:
Trade /Proprietary Name: ScanX Edge Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH
- Device Name:
-
- Legally Marketed Predicate Device Information: Trade/Device Name: ScanX Intraoral View K170733 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH
4
4. Device Description:
The ScanX Edge is a dental device that scans 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 intraoral Plates of the sizes 0, 1 and 2. intraoral plate Scanners are state of the art since 2002 and are available in various designs from many companies around the world. 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 635nm Laser. The laser beam is moved across the surface of 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.
-
- Intended Use/Indications for use:
The ScanX Edge is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
- Intended Use/Indications for use:
-
- Safety and Effectiveness:
The Edge 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 Edge were addressed by safety testing the device with Intertek to IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012 (Electrical Safety), IEC 60601-1-2:2014 (EMC) and IEC 60825-1 second edition (Laser safety). Design changes and risks associated with the introduction of the ScanX Edge were properly mitigated by DÜRR Dental's cGMP compliant Quality Management System, change control processes, risk assessments, and product validation. The ScanX Edge contains a Class 1 Laser Device as defined by 21 CFR 1040.10 The ScanX Edge is a non-patient contact Class II medical device.
- Safety and Effectiveness:
-
- Substantial Equivalence to Predicate Device Summary
DÜRR Dental's ScanX Edge is identical in function, and intended use to the DÜRR Dental ScanX Intraoral View K170733. Both units capture, digitize, and process intraoral x-ray images that are stored in imaging plate recording media.
- Substantial Equivalence to Predicate Device Summary
5
| Descriptive
Information: | Predicate Device:
ScanX Intraoral View
as cleared via 510(k) K170733 | Subject Device:
ScanX Edge | Change Impact Analysis: |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Photo | Image: ScanX Intraoral View | Image: ScanX Edge | Different look, same
functionalities. |
| Indications for
Use | The ScanX Intraoral View is
intended to be used for
scanning and processing
digital images exposed on
Phosphor Storage Plates
(PSPs) in dental applications. | The ScanX Edge is intended
to be used for scanning and
processing digital images
exposed on Phosphor
Storage Plates (PSPs) in
dental applications. | No change. |
| Mechanical
design | The exposed and unwrapped
plates are scanned in two
orthogonal directions using a
laser with a wavelength of
approximately 650 nm. | The exposed and
unwrapped plates are
scanned using a laser with a
wavelength of 650nm. The
scan pattern is not line by
line but follows a certain
geometrical figure. | Similar technology.
The ScanX Edge shows
different constructive
solutions for the
performance itself,
without influencing the
intended use or safety.
The operating principle is
still the same. The image
plates are scanned by a
laser light. |
| Electrical design | Light with a wavelength of
approximately 380 nm is
from the plate in proportion
to the number of captured x-
ray photons. This light is
collected and formed into an
image that may be viewed on
a video display and stored for
later recovery in a computer
memory. | Same principle. | Slightly different
implementation.
The difference lies within
the used laser diode. The
diode used in the ScanX
Edge is a fiber pigtailed
diode and the one used in
the ScanX Intraoral View is
a standard diode. Both
have identical
specifications concerning
the wavelength. |
| Descriptive
Information: | Predicate Device:
ScanX Intraoral View
as cleared via 510(k) K170733 | Subject Device:
ScanX Edge | Change Impact Analysis: |
| Image scanning | Laser / Photomultiplier Tube.
Components :
PHOTOMULTIPLIER 5 »
HAMAMATSU (Part-No. :
2151-150-50)
DIODE, LASER- 635nm/15mW
TO9 (Art-Nr.: 9135-80-002) | Laser / Photomultiplier Tube
Components :
Photomultiplier 2 »
Hamamatsu (Part-Nr. : 2160-
100189)
Diode, Laser 639nm/10mW
Pigtail (Art-Nr. :
9135100003) | No change: A laser and
photomultiplier tube
(PMT) is used for image
scanning. Different
components are used. The
ScanX Edge has a different
Laser Module and PMT
Module. The diode used in
the ScanX Edge is a fiber
pigtailed diode and the
one used in the ScanX
Intraoral View is a
standard diode. |
| Erasing the
residual image
following
scanning for
plate reuse | The residual image is erased
in the scanner by an inline
erasing function. | The residual image is erased
in the scanner by an inline
erasing function. | No change. |
| Viewing the
image | 4.3" Touch Screen. The touch
screen only shows a preview
which serves to provide an
initial impression of the final
x-ray image. For the purposes
of diagnosis, the x-ray image
must be viewed on a
diagnostic monitor. The
scanned images are displayed
on an internal LCD or an
external monitor using a
computer and user software
including image storage,
retrieval and manipulation. | The ScanX Edge does not
have a screen. | Different.
The 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. |
| Transport / feed
mechanism | The plates are transported by
"beltways" down the axis of
the cylinder past the slot. The
motion of the laser and
plates provides the two
orthogonal scan directions.
This is a continuous feed
device that allows successive
plates to be loaded as soon
as the previous plates have
moved past the slot. | The plates are inserted into
a size specific
interchangeable insert. If the
user wants to scan a
different plate size, the
insert needs to be
exchanged. The insert is
used to transport the plate
into the scanning position.
During the scanning process
the plate is not move. Upon
completion of the scanning
process the plate is moved
towards the discharging
position Afterwards the | Different.
The ScanX Edge shows
different constructive
solutions for the
performance itself,
without influencing the
intended use or safety.
The operating principle is
still the same by means of
that the image plate is
transported in the scan
position. After the
scanning procedure the
image plate is ejected
from the device. |
| Descriptive
Information: | Predicate Device:
ScanX Intraoral View
as cleared via 510(k) K170733 | Subject Device:
ScanX Edge | Change Impact Analysis: |
| | | plate is ejected from the
device. | |
| Plates to be
used with the
device | Dental intraoral
Size 0: 22 x 35 mm
Size 1: 24 x 40 mm
Size 2: 31 x 41 mm
Size 3: 27 x 54 mm
Size 4: 57 x 76 mm | Dental Intraoral
Size 0: 22 x 35 mm
Size 1: 24 x 40 mm
Size 2: 31 x 41 mm | Similar.
The ScanX Edge is used
with the smaller phosphor
plates only: Size 0, 1 and 2.
The phosphor plate sizes
are within the Intended
Use as defined by the
predicate device. |
| Image quality | Theoretical resolutions:
10, 20, 25 or 40 LP/mm | Max. theoretical resolution
Approx. 16.7 Lp/mm | Similar. |
| MTF | More than 45% at 3 lp/mm | More than 40% at 3 LP/mm | Similar. The measurement
was done on the basis of
IEC 62220-1 with minor |
| DQE | More than 7.5% at 3 lp/mm | More than 3,4% at 3 LP/mm | IEC 62220-1 with minor
deviations due to the
dental application of the
radiography device. The
lower DQE did not
adversely affect image
quality as shown by our
SSD testing. |
| Image data
bit depth | 16 bits | 16 bits | No change. |
| Product size
and weight | 380 x 410 x 450 [mm];
(W x L x H)
19.5 [kg] (42.99 lbs.) | 167x231x216
(W x L x H)
Approx. 4 Kg (8,82 lbs.) | Different. No impact on
safety/effectiveness. |
| Imaging
Software | • DBSWIN/VistaEasy | • DBSWIN/VistaEasy,
K190629
• VisionX K192743 | The ScanX Edge can be
used with the imaging
software DBSWIN and
VisionX. |
| Energy Source
AC | 100 to 240VAC, 50/60 Hz | 100 to 240VAC, 50/60 Hz | No change. |
| Patient
Contamination
prevention | Single patient use barrier
envelope encloses the
imaging plate while in the
patient's mouth. | Single patient use barrier
envelope encloses the
imaging plate while in the
patient's mouth. | No change. (Cleared in
K190949) |
| Descriptive
Information: | Predicate Device:
ScanX Intraoral View
as cleared via 510(k) K170733 | Subject Device:
ScanX Edge | Change Impact Analysis: |
| RFID | The ScanX Intraoral View
does not support the RFID
function | The ScanX Edge supports
image plates with RFID Tags.
The RFID tag is programmed
with the following
information:
-
Brandname DD, AT,
-
OEM.
-
HIBC
-
Date of production
-
Type of image plate | Different. The RFID
performance has no influence
on the intended use or safety
of the device.
The information on the RFID
Tag is used to identify the
image plate as a specific
plate. |
| Electronic User
Manual | User manual is provided in
printed form to the user. | The user manual is provided
in electronic form to the
user. | Different. In accordance with
the FDA Guidance
"Acceptable Media for
electronic Product User
Manuals" issued on 18 March
2010, the user manual can be
provided in electronic form
only. No additional storage
medium (DVD, or USB-Stick)
will be provided. The user
manual can be downloaded
from the website of Air
Techniques. Paper copies will
be provided upon request. |
| Standards
Compliance | US Performance Standard for
Lasers 21CFR1040
IEC 60825-1 Edition 2.0 2007-03,
safety of laser products - part I:
equipment classification, and
requirements
IEC 61010-1 :2010 (Third
Edition), Safety Requirements
for Electrical Equipment for
Measurement,
Control and Laboratory Use Part
1: General Requirements
EN 61326-1 :2013, Electrical
Equipment for Measurement,
Control and Laboratory Use,
EMC requirements | US Performance Standard for
Lasers 21CFR1040
IEC 60825-1 - TEST REPORT
Safety of laser products - Part
1: Equipment classification and
requirements
IEC 60601-1 Medical electrical
equipment
Part 1: General requirements
for basic safety and essential
performance
IEC 60601-1-2:2014, EN 60601-1-2:2015 EMC Professional
healthcare facility environment
/ Emission class B) | Standards chosen are more
suitable for use in the
healthcare environment | -
- Table of comparison to Legally Marketed Device:
6
7
8
The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness.
-
- 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 Drug Administration Staff Document Issued on: October 2, 2014
- Summary of non-clinical performance testing:
9
This device meets the applicable portions of the following international standards:
IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint) 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 and DQE image performance testing was performed with reference to IEC 62220-1:2003. 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, Document issued on: September 1, 2016.
The development of labeling was done in accordance with the FDA Guidance Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017. 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 Document issued on: August 14, 2013
-
- Summary of clinical performance testing: Not required to establish substantial equivalence.
-
- 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 Edge is safe and effective and substantially equivalent to the predicate device as described herein.