(28 days)
Not Found
No
The description focuses on standard digital radiography processing techniques (filtering, gain/offset correction, flat fielding) and does not mention any AI or ML algorithms for image analysis, interpretation, or other functions. The "Mentions AI, DNN, or ML" field is also "Not Found".
No.
The device is described as a dental imaging system used for capturing, digitizing, and processing intraoral x-ray images, which are diagnostic functions, not therapeutic ones.
No
Explanation: The device is an imaging system that captures, digitizes, and processes x-ray images. While it produces "diagnostic images," its function is image acquisition and processing, not the diagnostic interpretation itself. The "Intended Use" states it is "indicated for capturing, digitization and processing of intra oral x-ray images," which supports its role as an imaging tool rather than a diagnostic one.
No
The device description clearly outlines hardware components like a laser scanner, light collection system, and a mechanism for erasing imaging plates, in addition to the software for image processing and viewing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The ReadeR system is a dental imaging system that captures, digitizes, and processes intraoral x-ray images. It works with imaging plates exposed to x-rays of the intraoral complex of the skull.
- No Sample Analysis: The device does not analyze biological samples from the patient. It processes images generated by external radiation (x-rays) interacting with the patient's anatomy and recorded on an imaging plate.
Therefore, the ReadeR system falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ReadeR is a dental imaging system indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The ReadeR is a computer radiography system which produces the x-ray diagnostic image in digital format instead of using traditional screens and film. This device does not have a wireless transmission. The device utilizes reusable x-ray storage phosphor plate (IP) that is sensitive to x-ray and stores latent image when it is exposed to x-ray. After x-ray exposure to the x-ray storage phosphor plate, x-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the x-ray storage phosphor plates is released in a form of light by laser scanning. Then the light is collected and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain and offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, the stored locally, sent to an archive, printed or sent to PACS system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
intraoral complex of the skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist and other qualified dental professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: Image testing was performed to check image quality and resolution. Some of these test results are shown in the comparison table above. A quality assurance procedure and inspection was performed on the imaging plates and all testing was approved and standards were met since the predicate has CE mark and the same accessories are supplied for the subject device. Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modification of the device (note CR reader technology that is identical to the predicate) but they provide further evidence in addition to the bench performance data to show that the CR system works as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2016
Trident s.r.l. % Mr. Claude Berthoin President Denterprise International, Inc. 100 East Granada Blvd., Suite 219 ORMOND BEACH FL 32176
Re: K160386 Trade/Device Name: ReadeR. VieweR. OuickScan PSP Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 08, 2016 Received: February 11, 2016
Dear Mr. Berthoin:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oels
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160386
Device Name ReadeR, VieweR, QuickScan PSP
Indications for Use (Describe)
ReadeR is a dental imaging system indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
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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Image /page/3/Picture/0 description: The image is a black and white drawing of an eagle. The eagle is facing to the right, and its wings are spread out. The eagle's head is turned to the side, and its beak is open. The eagle's feathers are detailed, and the overall image is well-drawn. The eagle appears to be in flight.
510k FDA Consulting
Medical Device Clearance
100 East Granada Blvd., Suite 219
Ormond Beach, FL 32176
386-506-8711
510(k) Summary
Submitter/Applicant
Trident s.r.l. Via Verdi 20 Assago, Milan 20090, Italy Phone: +39-02-87072380 Fax: +39-02-87072381 Contact: Giorgio Rizzo, President (giorgio.rizzo33@gmail.com)
Date Prepared: February 08, 2016
Preparer/Consultant
Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
Phone: 386-506-8711 Fax: 855-235-7902 Contact: Joyce St. Germain, Regulatory Executive (Joyce@510kfda.com) Secondary Contact: Claude Berthoin, President (Claude@denterpriseintl.com)
Device Classification
| Trade/Model Names: | ReadeR, VieweR, QuickScan PSP |
|---|---|
| Common Name: | Computed Radiography Scanner System |
| Classification Name: | System, X-Ray, Extraoral Source, Digital |
| Regulation Name: | Extraoral source x-ray system |
| Regulation Number: | 21 CFR 872.1800 |
| Product Code: | MUH |
| Regulatory Class: | 2 |
| 510k Review Panel: | Radiology |
| Regulation Medical Specialty: | Dental |
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Predicate Device
The subject device claims equivalence to the following legally marketed predicate:
| 510(k) Number: | K143703 |
|---|---|
| Date Cleared | March 18, 2015 |
| Trade Name: | NICAL SMART MICRO CR System for Intraoral Dental |
| Images | |
| Common Name: | Computed Radiography Scanner System |
| Classification Name: | System, X-ray, Extraoral Source, Digital |
| Regulation Name: | Extraoral source x-ray system |
| Regulation Number: | 21 CFR 872.1800 |
| Product Code: | MUH |
| Regulatory Class: | 2 |
| Medical Specialty: | Dental |
| 510k Review Panel: | Radiology |
Indications for Use
ReadeR is a dental imaging system indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media.
Intended Use
ReadeR system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.
It is possible for both tooth decay and periodontal disease to be missed during a clinical exam, and radiographic evaluation of the dental and periodontal tissues is a critical segment of the comprehensive oral examination. In some cases extensive decay has been overlooked by a number of dentists prior to radiographic evaluation. So, the sensors and the PSP plates are in the best interest of the patient for improved healthcare. The ReadeR is a necessity for the dental office that is using the PSP plates.
Device Description
The ReadeR is a computer radiography system which produces the x-ray diagnostic image in digital format instead of using traditional screens and film. This device does not have a wireless transmission. The device utilizes reusable x-ray storage phosphor plate (IP) that is sensitive to x-ray and stores latent image when it is exposed to x-ray. After x-ray exposure to the x-ray storage phosphor plate, x-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the x-ray storage phosphor plates is released in a form of light by laser scanning. Then the light is collected and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain and offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, the stored locally, sent to an archive, printed or sent to PACS system.
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After acquisition of the latent image from the x-ray storage phosphor plate, it is erased thoroughly to be reused.
Comparison of Technological Characteristics with Predicate
The indications for use of the subject and predicate devices are identical and the technologies are substantially equivalent.
The imaging plates are exposed to x-rays while in the patient's mouth. The plates are removed and scanned by the scanning device. The images can be viewed by the dentist and stored on a personal computer. The plates are then erased and reused.
Patient cross contamination is prevented by the use of disposable, single use plate covers.
The imaging plates are identical to those used in the predicate device, as both systems are sharing the main part (CR Reader), the only difference with the subject and predicate device is the outside cover of the devices for private labeling. (The predicate device is horizontal and the subject device is vertical.)
The following table compares technological and other characteristics of the subject and predicate device.
| | | Trident
ReadeR
510(k) number unknown | Nical Smart Microchip CR
K 143703 |
|-----------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | The ReadeR system is indicated
for capturing, digitization and
processing of intra oral X-Ray
images stored in imaging plate
recording media. | Nical Smart Microchip CR system
is indicated for capturing,
digitization and processing of
intra oral X-Ray images stored in
imaging plate recording media. |
| Physical
characteristics | Imaging
plate size | Size 0 (22mm x 31mm),
Size 1 (24mm x 40mm),
Size 2 (31mm x 41mm),
Size 3 27mm x 54mm) | Size 0 : 22 x 31mm
Size 1 : 24 x 40mm
Size 2 : 31 x 41mm
Size 3 : 27 x 54mm |
Table of Comparison
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| | Trident
ReadeR
510(k) number unknown | Nical Smart Microchip CR
K 143703 |
|--------------------------|---------------------------------------------------|---------------------------------------------------|
| Effective
pixel pitch | 30 μ | 30 μ |
| Spatial
resolution | 10.5 lp/mm @ 30μm | 10.5 lp/mm @ 30μm |
| | Size 0: 343 x 484 @ 64um
628 x 885 @ 35um | Size 0: 343 x 484 @ 64um
628 x 885 @ 35um |
| Image
Matrix | Size 1: 375 x 625 @ 64um
685 x 1143 @ 35um | Size 1: 375 x 625 @ 64um
685 x 1143 @ 35um |
| | Size 2: 484 x 640 @ 64um
886 x 1171 @ 35um | Size 2: 484 x 640 @ 64um
886 x 1171 @ 35um |
| | Size 3: 891 x 1783 @ 30 um | Size 3: 891x 1783 pixel 30 um |
| Weight | 4.6 kg | 4.7 kg |
| Imaging device | High Sensitivity Photo Multiplier
Tube (s-PMT) | High Sensitivity Photo Multiplier
Tube (s-PMT) |
| Operational
| characteristics | Operating | Temperature :15-30°C | RH Temperature: 10 - 40 °C |
|---|---|---|---|
| Conditions | Humidity: 15%-95% | Humidity: 30 - 90% RH | |
| Power | 100-240V, 50/60Hz | 100-240V, 50/60Hz | |
| Method of | |||
| imaging | Register Patient -> X-ray | ||
| Exposure | Register Patient -> X-ray | ||
| Exposure | |||
| Image | |||
| receptor | Imaging plate | Imaging plate | |
| Functional | |||
| characteristics | Output data | DICOM 3 compatible | DICOM 3 compatible |
| Performance | MTF: 65Kv 0,1 sec exposure. | ||
| 100%. 1 lp/mm | |||
| 95%. 3 lp/mm | |||
| 80%. 5 lp/mm | |||
| 30%. 10 lp/mm | MTF: 70 kV 0.08 sec exposure. | ||
| 55% 1 lp/mm | |||
| 11% 3 lp/mm | |||
| Defect | |||
| compensation | By Imaging plate calibration | By Imaging plate calibration | |
| Dynamic | |||
| range | 16 bit | 16 bit | |
| Image | |||
| Processing | Single image processing | ||
| parameter is used | Single image processing | ||
| parameter is used | |||
| Imaging plate | |||
| characteristics | Composition | BaSrFBrl:Eu phosphor | |
| Thickness | approx. 350 mm | ||
| Typical | |||
| luminescence | 400 nm | ||
| Image | |||
| Retention | Recommended within 1 hour of | ||
| exposure. | |||
| Imaging | |||
| software | Deep-View | Nical Image Plus | |
| The two acquisition and imaging software are two Own Brand Labeling (OBL) of | |||
| the same original software Archimed Suite, that is CE certified with certificate | |||
| 1575/MDD issued by IMQ (Italy). | |||
| Deep-View holds the CE certificate number 1749/MDD, while Nical Image Plus | |||
| holds certificate number 1748/MDD, both release by IMQ (Italy). | |||
| The two software packages have the same functionalities, and differ only from the | |||
| aesthetic screens. |
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The above comparison shows the subject and predicate devices are substantially equivalent in technology characteristics. The differences are highlighted and none of these differences make the subject device any less safe and effective as the predicate device. The devices vary in weight by 0.1 kg. (ReadeR being lighter in weight) due to the outer covering of the devices. The operating temperatures vary, but these devices are used in an office setting and the temperature will be controlled to a comfortable median temperature of the operating temperature range. This is also due to the outer covering of the two devices being different. The MTF on performance is listed above and the variation is that the subject device is at 0.1 sec dose and the predicate is at 0.08 sec dose, so the percentages are different. All other technological characteristics are identical. The subject and predicate devices are identical except for the outer cover and the subject device stands vertically and the predicate device is horizontal.
Non-Clinical Performance Data
The following performance data is provided in support of the substantial equivalence determination. All tests performed are included in this submission.
Biocompatibility ... This device does not require a biocompatibility evaluation. The plate covers are commonly used and have previous approval.
Electrical Safety and EMC ... testing was performed by a qualified testing laboratory according to IEC 60601-1 and IEC 60601-1-2. The device met the requirements according to these standards and was performed by Prima Ricercaq & Sviluppo S.r.1. of Italy.
Software ... validation of software (EN 62304) and risk analysis (ISO 14971:2012) were performed and were met according to these standards. IEC 62366:2007 for use in conjunction with 60601-1-6:2010 was performed by TUV Rheinland North America and the standards were met.
Performance Testing ... Image testing was performed to check image quality and resolution. Some of these test results are shown in the comparison table above. A quality assurance procedure and inspection was performed on the imaging plates and all testing was approved and standards were met since the predicate has CE mark and the same accessories are supplied for the subject device. Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modification of the device (note CR reader technology that is identical to the predicate) but they provide further evidence in addition to the bench performance data to show that the CR system works as intended.
Conclusion
The subject and predicate devices have the same intended use and are substantially equivalent in technological characteristics and performance (since they are, in fact, the same device, with different branding for marketing purposes). The ReadeR does not raise any
9
questions regarding safety and effectiveness since it is the same as the predicate device. The non-clinical data supports and demonstrates the safety of the device.
The conclusion is that ReadeR (VieweR and QuickScan PSP) warrants a finding of substantial equivalence to the legally marketed original Nical Smart Micro CR System, and therefore, should have clearance for premarket activities in the United States.