(151 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on a combination of existing hardware and software with standard software validation and testing. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is intended to acquire digital radiographic images, which is a diagnostic function, not a therapeutic one.
No
Explanation: The device is intended to acquire digital radiographic images, which is an imaging function, not a diagnostic one. It provides images for a qualified/trained doctor or technologist to perform diagnosis, but it does not perform the diagnosis itself.
No
The device description explicitly states it is a "new combination of already cleared solid state digital x-ray acquisition panels and already cleared software," indicating it includes hardware components (the x-ray acquisition panels).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring digital radiographic images on patients. This is an in vivo (within a living organism) imaging process, not an in vitro (outside of a living organism) diagnostic test performed on biological samples.
- Device Description: The description mentions solid state digital x-ray acquisition panels and software, which are components of an imaging system, not a system for analyzing biological samples.
- Input Imaging Modality: The input is "Digital radiographic images," which are generated from X-rays passing through the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
The MasterX 800 Series is a medical device used for diagnostic imaging, specifically radiography.
N/A
Intended Use / Indications for Use
The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.
Product codes
MQB
Device Description
This device represents a new combination of already cleared solid state digital x-ray acquisition panels and already cleared software. It is suitable for use with adult and pediatric populations. This is an upgrade kit for existing or new systems. The purchaser may select their digital panel from this list:
InnoCare Model Name Yushan Series / MedicatechUSA Model Name Masterx80XX / 510(K) number / Size and Description
Yushan V14C / MasterX80IC / K201528 / 14X17 Csi Wireless Panel (Can work as Tethered)
Yushan V14G / MasterX801G / K201528 / 14X17 GOS Wireless Panel (Can work as Tethered)
Yushan F14C / MasterX802C / K210988 / 17X17 Csi Wireless Panel (can work as Tethered)
Yushan F14G / MasterX802G / K210988 / 17X17 GOS Wireless Panel (can work as Tethered )
Yushan V17C / MasterX803C / K201528 / Glassless 14X17 Csi Wireless Panel (Can work as Tethered)
Yushan V17G / MasterX803G / K201528 / Glassless 14X17 GOS Wireless Panel (Can work as Tethered)
Yushan V17Ce / MasterX804Ce / K220510 / 17X17 Csi Fixed Tethered Panel
Yushan V17Ge / MasterX804Ge / K201528 / 17X17 GOS Fixed Tethered Panel
As compared to our predicate system, the digital panels are more recently cleared by FDA. The image acquisition software is our Voyance software most recently cleared in K190601. The digital panels all comply with the voluntary IEC 60601-1 and IEC 60601-1-2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital radiographic images
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technologist. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work
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
Summary of non-clinical testing: We performed software validation and risk management for the updated software version. The following FDA guidances were employed in those activities: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. Our labeling reflects the FDA guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications. We performed integration testing to show that each panel performed correctly in the full system. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device.
Summary of clinical testing: Not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K190601, K201528, K210988, K220510
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
September 1, 2023
Medicatech USA % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K230918
Trade/Device Name: MasterX 800 Series Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: August 7, 2023 Received: August 7, 2023
Dear Daniel 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K230918
Device Name MasterX 800 Series
Indications for Use (Describe)
The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary, 510(k) Submitter: MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Free : +1 800 817 5030 Phone : +1 949 679 2881 FAX : +1 949 679 2882 Registration Number 3004989804 Contact: George Makar, Predsident Date Prepared: August 25, 2023
1. Identification of the Device:
Trade/Device Names: MasterX 800 Series Regulation Number: 21CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: MQB Common/Usual Name: Digital Diagnostic X-Ray System Upgrade
-
- Equivalent legally marketed device: K130377 Trade/Device Name: KrystalRad "New Series" Radiographic Portable Retrofit Manufacturer: MedicaTech USA Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: MQB Common/Usual Name: Digital Diagnostic X-Ray System Upgrade
-
- Reference Devices: Uses software cleared in our 510(k) number K190601, but updated. Uses one of the following previously cleared digital receptor panels, supplied unmodified:
| InnoCare Model Name Yushan Series | 510(K)
numbers | Product code/regulation |
|------------------------------------------------------------------|-------------------|-------------------------|
| Yushan V14C/ Yushan V14G/ Yushan V17C/ Yushan V17G/ Yushan V17Ge | K201528 | MQB/21CFR892.1680 |
| Yushan F14C/ Yushan F14G | K210988 | MQB/21CFR892.1680 |
| Yushan V17Ce | K220510 | MQB/21CFR892.1680 |
-
- Indications for Use The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.
-
- Description of the Device: This device represents a new combination of already cleared solid state digital x-ray acquisition panels and already cleared software. It is suitable for use with adult and pediatric populations. This is an upgrade kit for existing or new systems.
4
The purchaser may select their digital panel from this list:
| InnoCare Model
Name Yushan
Series | MedicatechUSA
Model Name
Masterx80XX | 510(K)
number | Size and Description |
|-----------------------------------------|--------------------------------------------|------------------|-----------------------------------------------------------|
| Yushan V14C | MasterX80IC | K201528 | 14X17 Csi Wireless Panel (Can work as Tethered) |
| Yushan V14G | MasterX801G | K201528 | 14X17 GOS Wireless Panel (Can work as Tethered) |
| Yushan F14C | MasterX802C | K210988 | 17X17 Csi Wireless Panel (can work as Tethered) |
| Yushan F14G | MasterX802G | K210988 | 17X17 GOS Wireless Panel (can work as Tethered ) |
| Yushan V17C | MasterX803C | K201528 | Glassless 14X17 Csi Wireless Panel (Can work as Tethered) |
| Yushan V17G | MasterX803G | K201528 | Glassless 14X17 GOS Wireless Panel (Can work as Tethered) |
| Yushan V17Ce | MasterX804Ce | K220510 | 17X17 Csi Fixed Tethered Panel |
| Yushan V17Ge | MasterX804Ge | K201528 | 17X17 GOS Fixed Tethered Panel |
As compared to our predicate system, the digital panels are more recently cleared by FDA. The image acquisition software is our Voyance software most recently cleared in K190601. The digital panels all comply with the voluntary IEC 60601-1 and IEC 60601-1-2.
-
- Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels (except for the Toshiba unit) and software.
7. Substantial Equivalence Chart:
| Item | K130377 KystalRad "New Series"
Radiographic Portable Retrofit | MasterX 800 Series | Comment |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indications
for Use: | Intended for use by a qualified/trained
doctor or technologist. As part of a
radiographic system, the KrystalRad
"New Series" is intended td acquire
digital radiographic images. It is
suitable for all routine radiography
exams, including specialist areas like
intensive care or trauma work,
excluding fluoroscopy, angiography and
mammography. | The MasterX 800 Series is intended for use
by a qualified/trained doctor or
technologist. As part of a radiographic
system, the MasterX 800 Series is intended
to acquire digital radiographic images on
adult and pediatric patients. It is suitable for
all routine radiography exams, including
specialist areas like intensive care or trauma
work, excluding fluoroscopy, angiography
and mammography. | Patient
population
added. |
| Configur-
ation of
Digital Panels | Battery or AC operated wireless IEEE
ac/a/g/n or Wired Ethernet (depending
on the model chosen) | Battery or AC operated wireless IEEE ac /
a/g/n or Wired Ethernet (depending on the
model chosen) | Exactly the
same. |
| Power
Source | AC Line or Rechargeable Battery
Battery life up to 8 hours | AC Line or Rechargeable Battery
Battery life up to 8 hours
Some models use AC Line only. See chart
above. | SAME |
| Item | K130377 KystalRad "New Series"
Radiographic Portable Retrofit | MasterX 800 Series | Comment |
| Digital Panel
Models | Vieworks Vivix-S K122866 or
Vivix-S Wireless K122865 | 8 new models from InnoCare, see list in
paragraph 5, above. | Newer
models |
| Panel
Performance | DQE @ 1lp/mm : 50 %
MTF @ 1lp/mm : 60 % | DQE at 1 lp/mm, 50%
MTF @ 1 lp/mm, 63% | Similar |
| Interface | Tethered or Wireless | Tethered or Wireless (See table above) | SAME |
| Photo
(example) | Image: Two radiographic panels, one with a cable attached. | Image: Two radiographic panels. | Similar
appear-
ance. |
| Panel sizes | 14" x 17" or 17" x 17" | SAME sizes are available. | SAME |
| X-ray
Conversion
Layer | Cesium lodide (Csl) with Amorphous
Silicon (a-Si) Photodiode | Csi OR GOS (GOS is lower cost but has nearly
comparable peformance) | SAME |
| Active Areas | Wired panel pixels:
2,560 x 3,072, or 3,072 x 3,072
or Wireless panel pixels
2560 x 3072 | MasterX80IC/G: 2500 x 3052
MasterX802C/G: 2500 x 3052
MasterX803C/G: 3072 x 3072
MasterX804Ce/Ge: 3072 x 3072 (wired
only) | Nearly
identical |
| Pixel pitch | 140 μm | 140 μm | SAME |
| A/D
Conversion | 14 Bits | All the new panels have 16 bit conversion | Better |
| Image
acquisition
software | Voyance | Voyance | SAME |
| DICOM | DICOM 3 | DICOM 3 | SAME |
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- Summary of non-clinical testing: We performed software validation and risk management for the 8. updated software version. The following FDA guidances were employed in those activities: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. Our labeling reflects the FDA guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications. We performed integration testing to show that each panel performed correctly in the full system. The software comlies with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device
6
- Summary of clinical testing: Not required. 9.
-
- Conclusion: After analyzing software integration validation, safety testing data, and test MasterX 800 Series images, it is the conclusion of Medicatech USA that the MasterX 800 Series system is as safe and effective as the predicate device, has insignificant technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.