(174 days)
No
The document describes image processing for tomographic reconstruction but does not mention AI or ML.
No.
This device is an imaging system designed to provide high-detail radiographic images of surgically excised medical specimens, which is a diagnostic rather than a therapeutic function.
No
The device is used to provide X-ray images of harvested specimens, which are then evaluated by physicians. It generates images for evaluation, but does not autonomously provide a diagnosis.
No
The device is a cabinet X-ray system, which is a hardware device. While it includes software for image processing and reconstruction, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide X-ray images of harvested specimens. This is an imaging device used to visualize the physical structure of the specimen.
- Device Description: The description focuses on the X-ray technology, image acquisition, and image processing to create visual representations of the specimen.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens in vitro (outside the body) to provide information about a patient's health status, disease, or condition. This often involves analyzing biological markers, chemical substances, or cellular components. The MOZART Supra system does not perform these types of analyses. It provides images, which are then interpreted by a healthcare professional.
The device is a medical imaging system for specimens, not a diagnostic test performed on the specimen itself to determine a medical condition.
N/A
Intended Use / Indications for Use
The MOZART® Supra® Specimen Tomosynthesis System is a cabinet X-ray system that is used to provide 2dimensional and 3-dimensional tomographic digital X-ray images of harvested specimens from various anatomical regions.
Product codes (comma separated list FDA assigned to the subject device)
MWP
Device Description
The MOZART SUPRA (XPERT84) Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens both in two-dimensional and three-dimensional tomosynthesis views.
- It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology.
- Creates images in 1mm digital slices of the specimen, allowing physicians to ● evaluate the specimen layer by layer.
Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these slices multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.
Tomosynthesis provides visualization of human anatomy by
-
- Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a two dimensional presentation, and
-
- Producing a number of slice images throughout the entire volume of the anatomy
The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software.
To support the Tomosynthesis application, the predicate device, MOZART SUPRA (XPERT84), K200756, has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and an Amorphous Selenium detector mounted stationary in the bottom of the cabinet xray unit
Mentions image processing
Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
harvested specimens from various anatomical regions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The previous claims have been proven internally and validated and verified via imaging of line-pair gauges and phantoms.
They have been clinically validated by reads of excised breast biopsies by a board certified radiologist.
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
§ 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
September 20, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
KUB Technologies, Inc. % Chester Lowe, Ph.D. Chief Technology Officer 111 Research Drive STRATFORD CT 06615
Re: K210955
Trade/Device Name: Kubtec MOZART SUPRA (XPERT 84) Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MWP Dated: August 27, 2021 Received: August 30, 2021
Dear Dr. Lowe:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210955
Device Name Kubtec MOZART SUPRA (Xpert 84) radiography system
Indications for Use (Describe)
The MOZART® Supra® Specimen Tomosynthesis System is a cabinet X-ray system that is used to provide 2dimensional and 3-dimensional tomographic digital X-ray images of harvested specimens from various anatomical regions.
| 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
Image /page/3/Picture/0 description: The image contains two logos for KUBTEC. The first logo is for "KUBTEC MEDICAL IMAGING" and the word "KUBTEC" is in blue. The second logo is for "KUBTEC SCIENTIFIC IMAGING" and the word "KUBTEC" is in orange. The word "MEDICAL" and "SCIENTIFIC" are smaller than the word "KUBTEC".
Kubtec MOZART SUPRA (XPERT 84) Premarket Notification 510(k) Summary K210955
Identification of Devices:
| Proprietary/Trade Name: | Kubtec MOZART SUPRA (XPERT84) Radiography System |
|---|---|
| Classification name: | Cabinet X-ray System |
| Classification: | Class II |
| CFR Section: | 21 CFR 892.1680 |
| Product Codes: | MWP |
| Common Name: | Stationary X-ray System |
Applicant:
KUB Technologies, Inc. 111 Research Drive Stratford, CT 06615 USA
Contact Person:
| Name: | Chester Lowe, Ph.D. |
|---|---|
| Title: | Chief Technology Officer |
| Telephone: | +1.203.364.8544 |
| Facsimile: | +1.203.255.7494 |
| Email: | CLowe@kubtec.com |
Establishment Number: KUB Technologies, Inc. # 3006051164
INDICATIONS FOR USE I.
The MOZART® Supra® Specimen Tomosynthesis System is a cabinet X-ray system that is used to provide 2-dimensional and 3-dimensional tomographic digital X-ray images of harvested specimens from various anatomical regions.
4
Image /page/4/Picture/0 description: The image shows two logos for KUBTEC. The first logo is for KUBTEC Medical Imaging, with the word "KUBTEC" in blue and the words "MEDICAL IMAGING" in a smaller font size below it. The second logo is for KUBTEC Scientific Imaging, with the word "KUBTEC" in yellow and the words "SCIENTIFIC IMAGING" in a smaller font size below it.
II. DEVICE DESCRIPTION
The MOZART SUPRA (XPERT84) Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens both in two-dimensional and three-dimensional tomosynthesis views.
- It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology.
- Creates images in 1mm digital slices of the specimen, allowing physicians to ● evaluate the specimen layer by layer.
Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these slices multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.
Tomosynthesis provides visualization of human anatomy by
-
- Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a two dimensional presentation, and
-
- Producing a number of slice images throughout the entire volume of the anatomy
The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software.
To support the Tomosynthesis application, the predicate device, MOZART SUPRA (XPERT84), K200756, has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and an Amorphous Selenium detector mounted stationary in the bottom of the cabinet xray unit
III. SUMMARY OF STUDIES AND SAFETY
Kubtec successfully completed internal and external safety testing requirements to the following standards The software and verification testing was also performed.
The Proposed MOZART SUPRA (XPERT84) with a-Se detector was successfully tested by INTERTEK to IEC 61010-1 Safety requirements for electrical equipment for
5
Image /page/5/Picture/0 description: The image shows two logos for KUBTEC. The top logo is for "KUBTEC MEDICAL IMAGING" with "KUBTEC" in a larger, bold, blue font and "MEDICAL IMAGING" in a smaller, lighter blue font underneath. The bottom logo is for "KUBTEC SCIENTIFIC IMAGING" with "KUBTEC" in a larger, bold, yellow font and "SCIENTIFIC IMAGING" in a smaller, lighter yellow font underneath.
measurement, control, and laboratory use - Part 1: General requirements as well to EMC Directive 2004/108/EC
Design controls and design transfer with appropriate risk management and analysis have been maintained per ISO 13485:2016, KUBTEC's Standard Operating Procedures via Quality and Regulatory Assurance (QARA) and Engineering, 21 CFR Part 820, and to 21 CFR 1020.40.
| Agency | Standard | Recognition
Number | Description |
|--------|----------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC | 60601-1-2 | 19-36 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests |
| IEC | 60601-1-10 | 19-37 | Medical electrical equipment - Part 1-10: General
requirements for basic safety and essential
performance - Collateral Standard: Requirements
for the development of physiologic closed-loop
controllers |
| IEC | 60601-1-11 | 19-38 | Medical electrical equipment - Part 1-11: General
requirements for basic safety and essential
performance - Collateral Standard: Requirements
for medical electrical equipment and medical
electrical systems used in the home healthcare
environment |
| IEC | 60601-1-12 | 19-39 | Medical electrical equipment - Part 1-12: General
requirements for basic safety and essential
performance - Collateral Standard: Requirements
for medical electrical equipment and medical
electrical systems intended for use in the
emergency medical services environment |
| IEC | 61010-1 | 19-34 | Safety requirements for electrical equipment for
measurement, control, and laboratory use - Part 1:
General requirements |
| IEC | 62304 1st Ed | 13-79 | Medical device software - Software life cycle
processes |
| ISO | 14971 2nd Ed | 5-40 | Medical devices - Application of risk management to
medical devices |
| ISO | 15223-1 | 5-117 | Medical devices - Symbols to be used with medical
device labels, labelling, and information to be
supplied - Part 1: General requirements |
| IEC | 61910-1 1st Ed | 12-290 | Medical electrical equipment - Radiation dose
documentation - Part 1: Radiation dose structured
reports for radiography and radioscopy |
111 Research Drive, Stratford, CT 06615 USA. Tel: +1(203) 364-8544; Fax:+1 (203) 255-7494 KUBTEC is a registered trademark of KUB Technologies, Inc.
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Image /page/6/Picture/0 description: The image shows a table with information about NEMA and CFR standards. The NEMA standard is PS 3.1 - 3.20 and 12-300 for Digital Imaging and Communications in Medicine (DICOM) Set. The CFR standard is 21 CFR 1020.40 and N/A for Cabinet X-Ray Systems. The image also contains the logos for KUBTEC MEDICAL IMAGING and KUBTEC SCIENTIFIC IMAGING.
IV. BASIS FOR THE SUBMISSION
The XPERT 84 Specimen Radiography System is a fully shielded Cabinet X-ray System that has been designed to comply with 21 CFR 1020.40. The system allows more than 20 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 20 microns. The x-ray coverage of the device allows the use of radiographic film sizes up to 35 x 43 cm. The device can also be configured to provide high resolution, DICOM compliant, digital images through the use of an integrated digital camera and Kubtec DIGICOM Specimen Radiography software. The Kubtec DIGICOM Software supports the DICOM Store, Print and Modality Worklist functionalities.
This device, MOZART SUPRA (XPERT84) will include a modification/replacement of the detectors in previously approved devices and functionally identical to the predicate devices. (See specifications in Section V) CMOS detector to an Amorphous SILICON detector
There is no change for the indication for use for the previously 510(k) approved device.
| Design and Use of the Device | |||
|---|---|---|---|
| Question | YES | NO | |
| Is the device intended for prescription use (21 CFR 801 Subpart D) ? | X | ||
| Is the device intended for over-the-counter use (21 CFR807 Subpart C)? | X | ||
| Is the device provided sterile? | X | ||
| Is the device intended for single use? | X | ||
| Is the device a reprocessed single use device? | X | ||
| If yes, does this device type require reprocessed validation data? | |||
| Does the device contain a drug? | X | ||
| Does the device contain a biologic? | X | ||
| Does the device use software? | X | ||
| Does the submission include clinical information? | X | ||
| Is the device implanted? | X |
7
Image /page/7/Picture/0 description: The image shows two logos for KUBTEC. The first logo is for KUBTEC Medical Imaging, with "KUBTEC" in blue and "MEDICAL IMAGING" in a smaller font size below it. The second logo is for KUBTEC Scientific Imaging, with "KUBTEC" in gold and "SCIENTIFIC IMAGING" in a smaller font size below it. The logos are stacked vertically, with the medical imaging logo on top.
V. SUBSTANTIAL EQUIVALENCE
The Kubtec MOZART SUPRA(XPERT84) Specimen Radiography System equipped with the Amorphous Selenium detector is substantially equivalent to the following currently cleared devices:
PRIMARY:
510(k) Number: K200756 Trade Name: Kubtec MOZART SUPRA (XPERT84) Specimen Radiography System
SECONDARY: 510(k) Number: K 111508 Trade Name: Hologic TRIDENT SPECIMEN RADIOGRAPHY 510(k) Number: K 193166 Trade Name: Siemens MAMMOMAT Revelation
Predicate Device:
| Device Name: | Kubtec MOZART SUPRA (XPERT84) |
|---|---|
| 510(k) Number: | K200756 |
| Classification | Class: II |
| Regulation Number: | 21 CFR 892.1680 |
| Product Code: | MWP |
| Regulation Name: | Stationary X-ray System |
| Device Name: | Hologic TRIDENT SPECIMEN RADIOGRAPHY |
| SYSTEM Model:RC | |
| 510(k) Number: | K111508 |
| Classification | Class: II |
| Regulation Number: | 21 CFR 892.1680 |
| Product Code: | MWP |
| Regulation Name: | Stationary X-ray System |
| Device Name: | Siemens MAMMOMAT Revelation |
| 510(k) Number: | K193166 |
| Classification | Class: II |
| Regulation Number: | 21 CFR 892.1715 |
| Product Code: | MUE |
| Regulation Name: | Full-field digital mammography system |
The proposed and predicate devices utilize similar technology and materials, comparable safety and effectiveness features, and is similar in design and construction.
The Indications for Use and labeling are virtually the same or similar and our labeling contain the required Cautions, Warnings and Contraindications consistent to those required for similar cleared devices.
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Image /page/8/Picture/0 description: The image shows two logos for KUBTEC. The top logo is for "KUBTEC MEDICAL IMAGING", with "KUBTEC" in a bold blue font and "MEDICAL IMAGING" in a smaller, lighter blue font underneath. The bottom logo is for "KUBTEC SCIENTIFIC IMAGING", with "KUBTEC" in a bold yellow font and "SCIENTIFIC IMAGING" in a smaller, lighter yellow font underneath.
Both systems produce digital images which can be sent to hardcopy printers, softcopy diagnostic workstations and/or stored in archive.
The proposed MOZART SUPRA(XPERT84) Specimen Radiography System, utilizes the predicate devices, MOZART SUPRA(XPERT84) Specimen Radiography System, with the same 90 kVp monobloc X-ray tube installed in the enclosed head of the cabinet as the predicate and both the Hologic TRIDENT(Predicate 2) and the proposed XPERT 84 Specimen Radiography System utilizes the Amorphous Selenium detector mounted stationary in the bottom replacing the predicate CMOS detector of the same shielded cabinet x-ray unit with proprietary software installed into an off the shelf personal computer, Microsoft Windows 10 Operating System, and a 2 megapixel or greater portrait type monitor.
The performance of the proposed AXS-2430V2 detector has been verified and cleared via 510k K193166 as incorporated into the Siemens MAMMOMAT Revelation.
Both systems utilize the same DIGICOM software.
The "Level of Concern" of MOZART SUPRA (XPERT 84) Specimen Radiography System software (DIGICOM) is "moderate"
The previous claims have been proven internally and validated and verified via imaging of line-pair gauges and phantoms.
| DETECTORS | |||||
|---|---|---|---|---|---|
| Currently Approved | |||||
| KUBTEC K200756 | Proposed | HOLOGIC APPROVED | |||
| K111508 | |||||
| Manufacturer | Manufacturer | Manufacturer | |||
| Rad-Icon | Analogic | Hologic | |||
| MFR | |||||
| Model # | 6K | 2329 | AXS-1824V2 | AXS-2430V2 | 1214 |
| KUBTEC | |||||
| SKU | DV136 | DV266 | DV210 | DV270 | n/a |
| Type | Active Pixel | ||||
| CMOS | Active Pixel | ||||
| CMOS | Amorphous | ||||
| Selenium | Amorphous | ||||
| Selenium | Amorphous Selenium | ||||
| Detection | |||||
| Method | In-direct | In-direct | Direct | Direct | Direct |
| Size (cm) | 11.4 x 14.5 | 22.8 x 29.1 | 17.4 x 23.9 | 23.9 x 30.5 | 12 x 14 |
| Resolution | 49.5μm | 49.5μm | 85μm | 85μm | 70μm |
| Pixel size | 2304 x | 4608 x 5890 | 2048 x 2816 | 2816 x 3584 | 2285 x 2571 |
They have been clinically validated by reads of excised breast biopsies by a board certified radiologist.
111 Research Drive, Stratford, CT 06615 USA. Tel: +1(203) 364-8544; Fax:+1 (203) 255-7494 KUBTEC is a registered trademark of KUB Technologies, Inc.
9
Image /page/9/Picture/0 description: This image shows a table with the specifications for the 2940 model. The table includes the DQE, MTF, and Bit Depth. The DQE at 1 Lp/mm is >45%, >55%, >50%, >70%, and >55%. The MTF at 1 Lp/mm is >80%, >85%, >90%, >95%, and >90%. The Bit Depth is 16 bits, 16 bits, 16 bits, 16 bits, and 14 bits.
Detector Specifications
Radiographic Magnification: 1.0x to 5x Exposure Control: Automatic or Manual X-ray Duty Cycle: 100%
Radiation Safety - 21CFR1020.40 Radiation shielded cabinet Compartment door equipped with dual safety interlocks
Radiation leakage:
Less than 0.1 mR/hr at 5 cm from any exterior surface at maximum kV.
VI. CONCLUSION
The Kubtec MOZART SUPRA (XPERT84) is as safe and effective as the predicate and previously approved MOZART SUPRA (XPERT84) devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices and conforms to applicable medical device safety standards.