(64 days)
Not Found
No
The summary describes a device for scanning and processing digital images from phosphor plates, focusing on hardware features, workflow, and image quality metrics. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No.
The device is an image processing system for X-ray images, used for diagnosis and not for treating or preventing disease.
Yes
The device "produces the digital diagnostic quality intraoral image" and the images are "useful for diagnosis".
No
The device description clearly outlines a physical device (scanner) that processes phosphor storage plates. While it utilizes software for image processing and management, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for scanning and processing digital images from PSPs in dental applications. This is related to medical imaging, specifically radiography, not the examination of specimens derived from the human body.
- Device Description: The device scans and processes images from X-ray exposed plates. It's a component in the workflow of acquiring and viewing dental radiographs.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the detection of specific analytes or markers.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to convert a latent image on a plate into a digital image for visual interpretation by a clinician.
N/A
Intended Use / Indications for Use
The ScanX Touch/ScanX Duo Touch is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The ScanX Touch 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 and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. Two models are available: The Scanx® Touch processes one imaging plate while ScanX® Duo Touch processes two at a time. The ScanX Touch also includes an RFID Phosphor Plate identification system which requires that the Phosphor Plate has an RFID tag attached to the non-imaging side of the Plate. ScanX allows multi room dental clinics to produce digital radiographs within seconds using a flexible PSP (Phosphor Storage Plates). The workflow is supported by a touch screen, for job handling (ScanManager, Patient information), preview and standalone work. ScanX produces the digital diagnostic quality intraoral image by scanning PSPs, which have been exposed to X-rays. ScanX can also work independently. If the IT network goes down, the user can still scan and save X-ray images. The images are temporarily placed in the internal memory and are later transferred to the office database. This makes the device ideally suited to provide a mobile solution when it is necessary to visit the patient outside the office. Additionally, ScanX allows computer storage, processing, retrieval and display of the processed images utilizing a user supplied software (e.g. DBSWIN) and computer. An additional feature of ScanX consists of an in-line plate eraser function that removes the latent image from the plate immediately after scanning. This design provides an efficient one-operation scanning and erasing process leaving the user with a PSP ready for the next X-ray procedure
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Dental intraoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed clinicians and authorized technicians / multi room dental clinics
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
Test images were acquired on the new device and on the predicate device. They were presented to a licensed dentist for his professional evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing:
Risk analysis and software validation was successfully performed.
EMC Testing according to IEC 60601-1-2 was successfully performed.
Electrical safety testing according to IEC 60601-1 was successfully performed.
Laser safety testing was performed according to IEC IEC 60825-1.
The unit is UL listed.
MTF and DQE image performance testing was performed with reference to IEC 62220-1:2003. Noise power spectrum measurements were documented.
The device was also tested by UL for compliance with FCC Part 15 subpart C for the internal RFID feature. The testing was successful.
Test images were acquired on the new device and on the predicate device. They were presented to a licensed dentist for his professional evaluation. The following questions were answered in the affirmative:
- The images acquired using the ScanX Duo Touch displayed in the dental imaging software are representative of customary intraoral X-rays.
- The images acquired using the ScanX Duo Touch are useful for a diagnostic purpose.
- The images acquired using the ScanX Duo Touch do not display any misleading artifacts that would hinder my ability to diagnose from.
- The images acquired using the ScanX Duo Touch are comparable to those images acquired using the ScanX Intraoral View.
Clinical performance testing: Not required to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF: More than 46% at 3 Lp/mm
DQE: More than 7.2% at 3 Lp/mm
Image data bit depth: 16 bits
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image is completely white and contains no discernible content. There are no objects, shapes, or patterns visible. The image appears to be a blank canvas.
August 21, 2019
Air Techniques, Inc. % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K191623
Trade/Device Name: ScanX Touch/ScanX Duo Touch Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: June 14, 2019 Received: June 18, 2019
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 (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 mediation-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
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Indications for Use
510(k) Number (if known) K191623
Device Name ScanX Touch/ScanX Duo Touch
Indications for Use (Describe)
The ScanX Touch/ScanX Duo Touch 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 |
Description 666 (Part 2: SPFL 001 Support B)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Air Techniques. The logo is blue and features the words "AIR TECHNIQUES" in a bold, sans-serif font. Above the word "TECHNIQUES" is the phrase "equipped for life" in a smaller font. The logo is simple and modern, and it conveys a sense of quality and reliability.
Air Techniques, 1295 Walt Whitman Road Melville, NY 11747 510(k) Summary K191623
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 15, 2019 1.
-
- Submitter's Identification: AIR TECHNIQUES, INC. 1295 Walt Whitman Road Melville, NY 11747 Tel: +1 (516) 214-5000 Internet: www.airtechniques.com
Contact: Warren Cheesman, Director of R&D Email: Warren.Cheesman@airtechniques.com AIR TECHNIQUES, INC. 1295 Walt Whitman Road Melville, NY 11747 Tel: +1 (516) 214-5550
-
- Device Name:
| Trade / Proprietary Name: | ScanX Touch/ScanX Duo Touch | |
|---|---|---|
| Regulation Number: | 21 CFR 872.1800 | |
| Regulation Name: | Extraoral source x-ray system | |
| Regulatory Class: | II | |
| Product Code: | MUH |
-
- Legally Marketed Predicate Device Information: K170733 Trade / Device Name: ScanX Intraoral View Manufactured by DUERR DENTAL AG Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: ll Product Code: MUH
-
- Device Description: The ScanX Touch 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 and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. Two models are available: The
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Scanx® Touch processes one imaging plate while ScanX® Duo Touch processes two at a time. The ScanX Touch also includes an RFID Phosphor Plate identification system which requires that the Phosphor Plate has an RFID tag attached to the non-imaging side of the Plate. ScanX allows multi room dental clinics to produce digital radiographs within seconds using a flexible PSP (Phosphor Storage Plates). The workflow is supported by a touch screen, for job handling (ScanManager, Patient information), preview and standalone work. ScanX produces the digital diagnostic quality intraoral image by scanning PSPs, which have been exposed to X-rays. ScanX can also work independently. If the IT network goes down, the user can still scan and save X-ray images. The images are temporarily placed in the internal memory and are later transferred to the office database. This makes the device ideally suited to provide a mobile solution when it is necessary to visit the patient outside the office. Additionally, ScanX allows computer storage, processing, retrieval and display of the processed images utilizing a user supplied software (e.g. DBSWIN) and computer. An additional feature of ScanX consists of an in-line plate eraser function that removes the latent image from the plate immediately after scanning. This design provides an efficient one-operation scanning and erasing process leaving the user with a PSP ready for the next X-ray procedure
-
- Indications for use: (Rx Only) The ScanX Touch/ScanX Duo Touch is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
-
- Safety and Effectiveness:
The ScanX Touch 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 Touch were addressed by safety testing the device with UL to IEC 60601-1 third edition (Electrical Safety), IEC 60601-1-2 (EMC) and IEC 60825-1 (Laser Safety). Design changes and risks associated with the introduction of the ScanX Touch / ScanX Duo Touch were properly mitigated by Air Techniques' cGMP compliant Quality Management System, change control processes, risk assessments, and product validation. The ScanX Touch contains a Class 1 Laser Device as defined by 21 CFR 1040.10. Installation and operation manuals are provided with instructions for safe use and servicing of the ScanX Touch. The ScanX Touch is a non-patient contact Class II medical device.
-
- Substantial Equivalence to Predicate Device Summary
Air Techniques' ScanX Touch is identical in function and intended use to the ScanX Intraoral View manufactured by Duerr Dental AG, whose dental units are in commercial distribution and are FDA cleared under 510K # K170733. The same engineering principles are used in both devices. ScanX Touch and the ScanX Intraoral View (predicate) both capture, digitize, and process intraoral X-ray images that are stored in imaging plate recording media.
- Substantial Equivalence to Predicate Device Summary
-
- Table of comparison to Legally Marketed Device:
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| Comparison
Criteria | Predicate Device: ScanX Intraoral
View, K170733, Duerr Dental AG | New Device: ScanX Touch/ScanX Duo Touch |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photo | Image: ScanX Intraoral View, K170733, Duerr Dental AG | Image: ScanX Touch/ScanX Duo Touch |
| 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 Touch/ScanX Duo Touch is
intended to be used for scanning and
processing digital images exposed on
photostimulable phosphor storage plates in
dental applications. (SAME) |
| Mechanical
Design | The exposed and unwrapped
plates are scanned in two
orthogonal directions using a laser
with a wavelength of
approximately 650 nm. | SAME as Predicate Device |
| 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 as Predicate Device |
| Image
Scanning | Laser/Photomultiplier Tube | SAME as Predicate Device |
| Erasing the
residual image
following
scanning for
plate reuse | The residual image is erased in the
scanner by an inline erasing
function. | SAME as Predicate Device |
| Comparison
Criteria | Predicate Device: ScanX Intraoral
View, K170733, Duerr Dental AG | New Device: ScanX Touch/ScanX Duo Touch |
| 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. | SAME as Predicate Device, except the Touch
Screen measures 7.0″ diagonal instead of
4.3". |
| 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. | SAME as Predicate Device |
| Phosphor
Plates | 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 | The ScanX Touch/ScanX Duo Touch operates
with the same (Dental intraoral) size AND
material Phosphor Plates as the ScanX
Intraoral View. The ScanX Touch also includes
an RFID Phosphor Plate identification system
which requires that the Phosphor Plate has an
RFID tag attached to the non-imaging side of
the Plate. |
| Image Quality | Theoretical resolutions: 10, 20, 25
or 40 Lp/mm | SAME as Predicate Device |
| MTF | More than 45% at 3 Lp/mm | More than 46% at 3 Lp/mm (essentially the
same) |
| DQE | More than 7.5% at 3 Lp/mm | More than 7.2% at 3 Lp/mm
(essentially the same) |
| Image data bit
depth | 16 bits | 16 bits, SAME |
| Body Size and
Weight | 380 x 410 x 450 mm (W x L x H)
19.5 kg 42.99 lbs. | 220 X 320 X 270 mm
8.0 kg, 17.6 lbs.
Slightly smaller/lighter |
| Comparison
Criteria | Predicate Device: ScanX Intraoral
View, K170733, Duerr Dental AG | New Device: ScanX Touch/ScanX Duo Touch |
| Imaging
Software | DBSWIN/VistaEasy as cleared in
K161444, updated in K190629 | SAME DBSWIN/VistaEasy have been updated
in K190629 |
| User Interface | It will be used by dentists and
authorized dental auxiliary
personnel. | SAME as Predicate Device |
| Energy Source
AC | 100 to 240VAC, 50/60 Hz | SAME as Predicate Device |
| Electrical
safety
standards | ΕΝ 61010-1:2010 Safety
Requirements for Electrical
Equipment for Measurement,
Control, and Laboratory Use - Part
1: General Requirements | IEC 60601-1 Electrical Safety Medical Devices.
UL Listed |
| EMC Testing | ΕΝ 61326-1:2013 Electrical
equipment for measurement,
control and laboratory use. EMC
requirements. General
requirements | IEC 60601-1-2 EMC Medical Devices
Also complies with EN 61326-1:2013, EMC
Requirements for Lab use and FCC rules part
15 (RFID feature) |
| Patient
Contamination
prevention | Single patient use barrier
envelope encloses the imaging
plate while in the patient's mouth. | We use the IDENTICAL single use barrier
envelopes as the Predicate Device |
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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: Prior to performance testing, labeling was developed to mitigate cybersecurity risks and risks to pediatric patients. The following guidance documents were consulted: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff OCTOBER 2014 and Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff NOVEMBER 2017. Risk analysis and software validation was successfully performed. EMC Testing according to IEC 60601-1-2 was successfully performed. Electrical safety testing according to IEC 60601-1 was successfully performed. Laser safety testing was performed according to IEC IEC 60825-1, Safety of laser products. The unit is UL listed. MTF and DQE image performance testing was performed with reference to IEC 62220-1:2003. Noise power spectrum measurements were documented. These FDA guidance documents were employed: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on: May 11, 2005 AND 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 device was also tested by UL for compliance with FCC Part 15 subpart C. The testing was successful. This was required because of the internal RFID feature. The device contains an NFC radio used for RFID. Test images were acquired on the new device and
8
on the predicate device. They were presented to a licensed dentist for his professional evaluation. The following questions were answered in the affirmative:
The images acquired using the ScanX Duo Touch displayed in the dental imaging software are representative of customary intraoral X-rays.
The images acquired using the ScanX Duo Touch are useful for a diagnostic purpose.
The images acquired using the ScanX Duo Touch do not display any misleading artifacts that would hinder my ability to diagnose from.
The images acquired using the ScanX Duo Touch are comparable to those images acquired using the ScanX Intraoral View.
-
- 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, Air Techniques, Inc. concludes that the ScanX Touch is safe and effective and substantially equivalent to the predicate device as described herein.