(170 days)
Not Found
No
The summary describes standard image processing and reconstruction techniques for 2D and 3D X-ray data, with no mention of AI or ML algorithms.
No.
The device is described for dental radiographic examinations to produce images (2D and 3D) for diagnostic purposes, not for providing therapy.
Yes
The device produces conventional 2D X-ray images and X-ray projection images for 3D reconstruction, and its stated intended use is for "dental radiographic examinations" of teeth, jaw, and TMJ areas, which are diagnostic examinations.
No
The device description explicitly states that the device consists of a "scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data." This indicates the presence of hardware components (the scanner) in addition to the software (the Console and 3D Viewer).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Panoura X-ERA PF/NF/MF is an X-ray imaging device. It produces images of the teeth, jaw, and TMJ areas using X-rays. It does not analyze biological specimens.
- Intended Use: The intended use clearly states "dental radiographic examinations," which involves imaging the body directly, not analyzing samples taken from the body.
Therefore, based on the provided information, the Panoura X-ERA PF/NF/MF is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for general populations. The device must only be operated and used by dentists and other legally qualified professionals.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is modified from the IMAGEWORKS PANOURA (K122806).
The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
Panoura X-ERA PF/NF/MF consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. The Console is new software and classified as moderate level concern. 3D Viewer will then perform the image analysis or image edition such as creating cross-section diagram.
3D sensor is not installed for Panoura X-ERA PF. Medium FOV sensor is installed for Panoura X-ERA NF. Large FOV sensor is installed for Panoura X-ERA MF.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw and TMJ areas
Indicated Patient Age Range
general populations
Intended User / Care Setting
dentists and other legally qualified 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)
Bench Testing
THE YOSHIDA DENTAL MFG. Co., LTD has compared test pattern images acquired using the proposed device with those images acquired using predicate device in accordance with FDA guidance entitled "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices".
The test pattern images of the proposed device and those of the predicate device were equivalent.
THE YOSHIDA DENTAL MFG. CO., LTD has also performed bench testing regarding laser safety to verify conformity with IEC 60825-1:2007 and 2014.
The software of the proposed device has been validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
EMC, Electric safety, and X-ray radiation safety are confirmed in accordance with IEC 60601-1-2:2007, IEC60601-1:2012, IEC 60601-1-3:2013, IEC60601-1-6:2010, IEC 60601-2-28:2010, IEC 60601-2-54:2015, and IEC 60601-2-63:2012.
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 31, 2019
The Yoshida Dental Mfg. Co., Ltd. Hidenori Watanabe Regulatory Affairs 1-3-6, Kotobashi SUMIDA-KU. 130-8516 JAPAN
Re: K182198
Trade/Device Name: Panoura X-ERA PF/NF/MF Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: December 14, 2018 Received: December 20, 2018
Dear Hidenori Watanabe:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Nils
for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182198
Device Name Panoura X-ERA PF/NF/MF
Indications for Use (Describe)
The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for general populations. The device must only be operated and used by dentists and other legally qualified professionals.
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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3
510(k) Summary
4
510(k) Summary
a. Owner/Company name, address THE YOSHIDA DENTAL MFG. CO., LTD. 1-3-6, Kotobashi, Sumida-ku
Tokyo 130-8516, Japan
▪ Contact person Hidenori Watanabe International Regulatory Affairs 011-81- 3-3631-2165 Phone: 011-81- 3-3633-9420 Fax: hi-watanabe@yoshida-net.co.jp Email:
b. Date prepared
September 20, 2018
c. Name of device
| Trade Name: | Panoura X-ERA PF/NF/MF |
|---|---|
| Regulation Name: | Extraoral source x-ray system |
| Classification Name: | System, x-ray, extraoral source, digital |
| Classification Regulation: | 21 CFR 872.1800 |
| Product Code: | MUH |
5
d. Predicate devices
Panoura X-ERA PF/NF/MF is substantially equivalent to the following legally marketed device:
| 510(k): | K122806 |
|---|---|
| Trade name: | IMAGEWORKS PANOURA |
| Regulation Name: | Extraoral source x-ray system |
| Classification Regulation: | 21 CFR 872.1800 |
| Product code: | MUH |
e. Description of the device
The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is modified from the IMAGEWORKS PANOURA (K122806).
The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
Panoura X-ERA PF/NF/MF consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. The Console is new software and classified as moderate level concern. 3D Viewer will then perform the image analysis or image edition such as creating cross-section diagram.
3D sensor is not installed for Panoura X-ERA PF. Medium FOV sensor is installed for Panoura X-ERA NF. Large FOV sensor is installed for Panoura X-ERA MF.
f. Indications for Use
The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The Panoura X-ERA PF/NF/MF dental panoramic and cephalometric device is intended for general populations. The device must only be operated and used by dentists and other legally qualified professionals.
6
g. Statement of substantial equivalence
Comparative Information
The Panoura X-ERA PF/NF/MF is modified from the IMAGEWORKS PANOURA (K122806).
Indications for use of the Panoura X-ERA PF/NF/MF is identical to that of the IMAGEWORKS PANOURA (K122806). Patient population and the fundamental technologies of the proposed device are identical to those of the predicate device.
The similarities are;
- Indications for use
- Operational characteristics ●
- Ionizing radiation ●
- Cephalometric radiogram
- Panoramic images ●
- 3D Imaging
The main changes of Panoura X-ERA PF/NF/MF from the predicate device are software and addition of an 3D sensor. The proposed device's software for image acquisition setting and creating images is entirely different form the predicate device's software.
Although the other 3D sensor is identical to the 3D sensor of the predicate device, the scanning mode setting is changed from the predicate device. The scanning mode for Panoura X-ERA PF/NF/MF was fast mode which is changed from fine mode for the predicate device. Following table shows comparison for 3D sensor and scanning mode between the proposed and predicate devices.
| Proposed device* | Predicate device | ||
|---|---|---|---|
| Device name or | |||
| model | Panoura X-ERA MF | Panoura X-ERA NF | IMAGEWORKS |
| PANOURA | |||
| (K122806) | |||
| Flat panel detector | C10900D-40 | C10901D-40 | |
| Manufacturer | Hamamatsu Photonics KK | ||
| Scanning mode | Fast mode | Fast mode | Fine mode |
| Image pixel size (µm) | 200 x 200 | 200 x 200 | 100 x 100 |
| Effective | |||
| photosensitive area | |||
| (mm) | 121.6 x 123.2 | 99.2 x 67.2 | |
| Number of pixels | 608 x 616 | 496 x 336 | 1008 x 682 |
| Readout circuit | Change amplifier array | ||
| Video data format | 13 bit | 13 bit | 12 bit |
| Scintillator | Directory deposited CsI | ||
| Frame rate (frame/s) | 10-35 | 10-60 | 10-30 |
| Noise (electrons) | 2900 | 2200 | 1300 |
Table 1 Comparison for 3D sensor and scanning mode
7
| Saturation charge
| (M electrons) | 10.5 | 10.5 | 2.2 |
|---|---|---|---|
| Sensitivity (LSB/mR) | 6000 | 6000 | 3500 |
| Resolution (Line pairs/mm) | 2.5 | 2.5 | 4.5 |
| Dynamic range | 3600 | 4700 | 1700 |
- 3D imaging is not available for Panoura X-ERA PF.
Following is comprehensive comparison table.
8
Table 2. Comparison Table
| Device Characteristics | Panoura X-ERA PF/NF/MF | IMAGEWORKS PANOURA (Κ122806) | |
|---|---|---|---|
| Indications for Use | The Panoura X-ERA PF/NF/MF dental panoramic | ||
| and cephalometric device is intended for dental | |||
| radiographic examinations of teeth, jaw and TMJ | |||
| areas by producing conventional 2D X-ray images | |||
| as well as X-ray projection images of examined | |||
| volume for the reconstruction of 3D view. The | |||
| Panoura X-ERA PF/NF/MF dental panoramic and | |||
| cephalometric device is intended for general | |||
| populations. The device must only be operated and | |||
| used by dentists and other legally qualified | |||
| professionals. | The IMAGEWORKS PANOURA dental | ||
| panoramic and cephalometric device is | |||
| intended for dental radiographic examinations | |||
| of teeth, jaw and TMJ areas by producing | |||
| conventional 2D X-ray images as well as | |||
| X-ray projection images of examined volume | |||
| for the reconstruction of 3D view. The device | |||
| must only be operated and used by dentists | |||
| and other legally qualified professionals. | |||
| Equipment type | Digital panoramic x-ray equipment | Same | |
| Mode of operation | Continuous operation with intermittent load | Same | |
| X-ray tube focal point | 0.2 mm×0.2 mm | 0.5 mm×0.5 mm | |
| X-ray tube cooling method | Oil cooling | Same | |
| Nominal maximum electric power | |||
| (combination of X-ray tube voltage | |||
| and tube current at maximum output) | 0.36kw (90kV, 4mA) | 0.82kW (82kV, 10mA) | |
| Tube voltage | 70 - 90 kV | 58 – 82 kV | |
| Tube current | 2 – 4 mA | 2.0 - 10 mA | |
| Panoramic | Regular 7.0, 12.0s | Adult 8, 14, 16s | |
| Low dose 5.9、10.1s | Child 6.4, 11.2, 12.8s | ||
| Radiation time | TMJ | 3.4s x 2 | 8s |
| Bitewing | 3.4s x 2 | - | |
| Cephalo | |||
| / Carpus image | |||
| acquisition | 8.0, 10.0, 12.0, 15,0s | 8-10s | |
| Radiation time | 3D | Panoura | |
| X-ERA MF Large FOV Low | |||
| dose mode 12.0s, 20.0s | |||
| Medium FOV | |||
| Low dose mode 12.0s, 20.0s | 3D oral mode: 11.5s x 2 | ||
| 3D dent mode: 11.5s |
9
| | | | Medium FOV
High quality
mode | 12.0s, 16.0s | |
|------------------------------------|-------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------------|
| | | | Small FOV
sensor High
quality mode | 12.0s, 16.0s | |
| | | | Medium FOV
Low dose mode | 12.0s, 20.0s | |
| | 3D | Panoura
X-ERA NF | Small FOV
sensor High
quality mode | 12.0s, 16.0s | |
| | | | | | |
| Electric power supply resistance | | Maximum 0.2 Ω | | | Same |
| | Total filtration | 2.5mmAl equivalent or over | | | Same |
| Leakage dose | | 1.0 mGy/h or less | | | Same |
| Leakage dose calculation standards | | | Tube voltage 90kV, tube current 4mA | | Tube voltage 82kV, tube current 10mA |
| Image magnification | Panoramic | 1.3 to 1.4 | | | 1.2 to 1.29 |
| | TMJ | 1.3 to 1.4 | | | 1.2 to 1.29 |
| | Bitewing | 1.3 to 1.4 | | | - |
| | Cephalo | 1.1 | | | 1.1 |
| | 3D | 1.0 | | | 1.0 |
| | Number of phases | Single phase | | | Same |
| | Frequency | 50 / 60 Hz | | | Same |
| Rated power | Voltage | AC100V - 120V / AC220V - 240V | | | Same |
| | Input | 110VAC | 1.5kVA | | 2.0kVA |
| | | 230VAC | 1.5kVA | | 2.0kVA |
| Classification | | Class I, Type B | | | Same |
| Up-and-down stroke | | 800 mm | | | 800 mm (short type: 400 mm) |
| Weight | | 150kg: Standing position wall-mount: Panoramic | | | 140kg Standing position, wall mount (with 3D |
| | | type | | | detector) |
| | | 205kg: Standing position base-mount: Panoramic | | | 135kg Standing position, wall mount (short |
| | | type | | | type) (with 3D detector) |
| | | 155kg: Standing position wall-mount: Large FOV | | | 165 kg Standing position, base mount with an |
| | | 3D type | | | optional base (in the case of wide base: +5kg) |
| | | | | | (with 3D detector) |
| | | | | | |
| Weight | | 210kg: Standing position base-mount: Large FOV 3D type | 160kg Standing position, base mount (short type) with an optional base (in the case of wide base: +5kg) (with 3D detector) | | |
| | | 190kg: Standing position wall-mount: Medium FOV 3D type | 180kg Standing position wall mount (with Cephalo) | | |
| | | 255kg: Standing position base-mount: Large FOV 3D Cephalometric 2-sensor type | 175kg Standing position, base mount (short type) (with Cephalo) (with 3D detector) | | |
| | | 190kg: Standing position wall-mount: Medium FOV 3D Cephalometric 2-sensor type | 205kg Standing position, base mount with an optional base (with Cephalo) (in the case of wide base: +5kg) (with 3D detector) | | |
| | | 255kg: Standing position base-mount: Medium FOV 3D Cephalometric 2-sensor type | 200kg Standing position, base mount (short type) (with Cephalo) (in the case of wide base: +5kg) (with 3D detector) | | |
| | | 190kg: Standing position wall-mount:
Cephalometric 1-sensor type | | | |
| | | 250kg: Standing position base-mount:
Cephalometric 1-sensor type | | | |
| | | 195kg: Standing position wall-mount: Large FOV 3D Cephalometric 1-sensor type | | | |
| | | 255kg: Standing position base-mount: Large FOV 3D Cephalometric 1-sensor type | - | | |
| | | 195kg: Standing position wall-mount: Medium FOV 3D Cephalometric 1-sensor type | | | |
| | | 255kg: Standing position base-mount: Medium FOV 3D Cephalometric 1-sensor type | | | |
| Size | | 2300 x 1070 x 1365 mm (Standing position wall-mount) | 2209 x 846 x 1192mm (Standing position wall mount) | | |
| | | 2300 x 1860 x 1365 mm (Standing position wall-mount with Cephalo) | 2209 x 1835 x 1192mm (Standing position wall-mount with Cephalo) | | |
| SID/SOD (Panoramic) | | 650 mm/435 mm (25.6inch / 17.1inch) | 485 mm / 350 mm | | |
| SID/SOD (Cephalo) | | 1650 mm/1500 mm (65.0inch / 59.1inch) | Same | | |
| SID/SOD (3D) | | 670 mm/435 mm (26.4inch / 17.1inch) | 570 mm / 350 mm | | |
| Operating environment | Temperature | 10 to 40°C | Same | | |
| | Relative humidity | 30 to 75% (no condensation) | Same | | |
| EMC Classification | | Class A | Same | | |
10
11
| Target angle | 10 degrees | 15 degrees | |
|---|---|---|---|
| Positioning laser lights | laser light (CLASS 1 LASER PRODUCT) | ||
| IEC60825-1:2007, IEC60825-1:2014 | laser light (CLASS 2 LASER PRODUCT) | ||
| IEC 60825-1:1993+A1:1997+A2:2001 | |||
| Cephalometric radiogram | Scanning method | ||
| Scanning time | Horizontal scan, synchronized sensor and secondary slot motion | ||
| 8 - 15s | Same | ||
| 8 - 10s | |||
| Panoramic image receptor | Sensor unit | Pan sensor or Detachable combination sensor for panorama and cephalometric | Detachable combination sensor for panorama and cephalometric |
| Technology | CMOS | Same | |
| Image pixel size | 100 x 100 μm | Same | |
| Image field height | 151mm / 1510 pixels | Same | |
| Cephalometric image receptor | Sensor unit | Detachable combination sensor for panorama and cephalometric | Same |
| Technology | CMOS | Same | |
| Image pixel size | 100 x 100 μm | Same | |
| Image field height | 226.6mm / 2266pixels | Same | |
| Image field width in LA view | |||
| Image field width in PA view | 254mm | ||
| 203.2mm | Same | ||
| Same | |||
| 3D image receptor | Sensor unit | 3D sensor | - |
| Technology | CMOS | - | |
| Image pixel size | 200 x 200 μm (Fast mode) | 100 x 100 μm (Fine mode) | |
| Image field height | 99.2mm/992pixels | Same | |
| 3D image receptor | Sensor unit | 3D sensor | - |
| Technology | CMOS | - | |
| Image pixel size | 200 x 200 μm (Fast mode) | - | |
| Image field height | 121.6 mm/608 pixels | - |
12
Bench Testing
THE YOSHIDA DENTAL MFG. Co., LTD has compared test pattern images acquired using the proposed device with those images acquired using predicate device in accordance with FDA guidance entitled "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices".
The test pattern images of the proposed device and those of the predicate device were equivalent.
THE YOSHIDA DENTAL MFG. CO., LTD has also performed bench testing regarding laser safety to verify conformity with IEC 60825-1:2007 and 2014.
The software of the proposed device has been validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
EMC, Electric safety, and X-ray radiation safety are confirmed in accordance with IEC 60601-1-2:2007, IEC60601-1:2012, IEC 60601-1-3:2013, IEC60601-1-6:2010, IEC 60601-2-28:2010, IEC 60601-2-54:2015, and IEC 60601-2-63:2012.
Conclusion
The Panoura X-ERA PF/NF/MF is modified from the predicate device. The changed points are evaluated with software validation and bench testing and did not raise new concern. THE YOSHIDA DENTAL MFG. Co., LTD. concludes that the Panoura X-ERA PF/NF/MF is substantially equivalent to the IMAGEWORKS PANOURA (K122806).