(88 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard X-ray imaging components and functionality.
No.
The device is described as an X-ray system for imaging and diagnosis, not for treating or rehabilitating medical conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for "imaging of the patient during diagnostic, surgical and interventional procedures." The "Device Description" also mentions its primary use for "diagnosis of diseases".
No
The device description explicitly lists multiple hardware components including a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, and a tube. While it includes operating software, it is part of a larger hardware system.
No, the FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. They perform tests on samples like blood, urine, tissue, etc., outside of the body (in vitro).
- The FLUSION-9001 is an imaging device. It uses X-rays to create images of the inside of a patient's body in vivo (within the living organism).
The description clearly states its purpose is to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical, and interventional procedures. This involves directly imaging the patient, not testing samples from them.
N/A
Intended Use / Indications for Use
The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedical, abdominal, vascular, cardias, critical care and emergency room procedures.
Product codes
OWB, OXO, JAA, IZI
Device Description
The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal. respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended to be used for mammography applications.
FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray, Radiographic X-ray
Anatomical Site
skeletal, respiratory, urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital (emergency room, operation room, cast room or etc.)
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
Performance evaluation (test) reports and device inspection report confirmed that the FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System is suitable for its intended use and user instruction of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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April 3, 2020
LiverMoreTech, Inc. % Mr. Dave Kim Regulatory Affairs MTech Group 7707 Fannin Street. Suite 200 HOUSTON TX 77054
Re: K200022
Trade/Device Name: FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA, IZI Dated: December 31, 2019 Received: January 6, 2020
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K200022
Device Name FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System
Indications for Use (Describe)
The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedical, abdominal, vascular, cardias, critical care and emergency room procedures.
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 K200022
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: April 1, 2020
I. SUBMITTER
| Submitter's Name | Livermoretech |
|---|---|
| Submitter's Address | 801 North Jupiter Rd, Suite 200 |
| Plano TX 75074 | |
| Submitter's Telephone | Tel: +1-214-257-0113 |
| Contact person | Jay Kim (jay.kim@aspenstate.com) / RA Manager |
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) |
| Address | 7707 Fannin St. Ste 200, V111, Houston, TX 77054 |
| Telephone | +713-467-2607 |
II. DEVICE
| Trade/proprietary Name | FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System |
|---|---|
| Regulation Name | Image Intensified Fluoroscopic Mobile X-ray System |
| Regulation Number | 21 CFR 892.1650 |
| Product Code | OWB, OXO, JAA, IZI |
| Regulatory Class | Class II |
III. PREDICATE DEVICE
| 510K Number | K032761 |
|---|---|
| Manufacturer | United Radiology Systems, Inc |
| Device Name | KMC-950 |
| Regulation Name | Image Intensified Fluoroscopic Mobile X-ray System |
| Regulation Number | 21 CFR 892.1650 |
| Product Code | OWB, OXO, JAA |
| Regulatory Class | Class II |
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IV. REFRENCE DEVICE
| 510K Number | K180473 |
|---|---|
| Manufacturer | ECOTRON Co., Ltd |
| Device Name | ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-Arm |
| Regulation Name | Image Intensified Fluoroscopic Mobile X-ray System |
| Regulation Number | 21 CFR 892.1650 |
| Product Code | OWB, OXO, JAA |
| Regulatory Class | Class II |
DEVICE DESCRIPTION: V.
The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal. respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended to be used for mammography applications.
FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.
Indications for Use: 21 CFR 807 92 (a) (5) VI.
The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.
Comparison Table with the Predicate Device for technological characteristics:
| Predicate device | Proposed device | SE | ||
|---|---|---|---|---|
| Model Name | KMC-950 | FLUSION-9001 | ||
| Fluoroscopic C-arm Mobile X-ray System | ||||
| 510(k) Number | K032761 | K200022 | ||
| Indications for Use | The KMC-950 is intended to | |||
| provide fluoroscopic and | ||||
| radiographic imaging of the | ||||
| patient during diagnostic, | ||||
| surgical and interventional | ||||
| procedures. Clinical | ||||
| applications may include but | ||||
| are not limited to digital | ||||
| subtraction angiography, | The FLUSION-9001 | |||
| fluoroscopic C-arm Mobile X-ray System is intended to | ||||
| provide fluoroscopic and | ||||
| radiographic imaging of the | ||||
| patient during diagnostic, | ||||
| surgical and interventional | ||||
| procedures. Clinical | ||||
| applications may include but | Similar | |||
| orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures. | ||||
| The system may be used for other RF imaging application at physician's discretion. | are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures. | |||
| X-ray Tube | Anode Type | Rotating | Rotating | Same |
| Heat Capacity | 300,000 HU | 300,000 HU | Same | |
| Anode Heat | ||||
| Cooling | 70kHU/min | 60kHU/min | Similar | |
| Focal size | 0.3mm / 0.6mm | 0.3mm / 0.6mm | Same | |
| Fluoroscopic | ||||
| Mode | kV range | 40 to 125 kV See below discussion for differences | 40 to 120 kV See below discussion for differences | Similar |
| mA range | 0.5 to 5 mA. See below discussion for differences | 0.2 to 8mA. See below discussion for differences | Similar | |
| Pulse Fluoro | Yes | Yes | Same | |
| ABS function | Yes | Yes | Same | |
| Detector | Manufacturer | Imaging Intensifier: | ||
| Thales (TH9428HP2) Image Intensifier | Imaging Intensifier: | |||
| E5830SD-P4A (TOSHIBA) | ||||
| Cleared under K160065 | ||||
| Size | 9" | 9" | Same | |
| Magnification | 9" / 6" / 4.5" | 9" / 6" / 4.5" | Same | |
| DQE | 65 | 65 (@ 0 lp/mm) | Same | |
| Camera | Type | 1/2" CCD | 1/2" CCD | Same |
| Active pixels | 512 x 512 | 1024 x 1024 | Better | |
| C-arm | Manufacturer | GEMSS medical | Livermoretech Inc. | |
| SID | 950mm | 1000mm | Similar | |
| Range of C-ram | ||||
| Rail Rotation | 115° | 135° | Wider | |
| Range of the | ||||
| Liner FR-arm | ||||
| Movement | 200 mm | 200 mm | Same | |
| Range of the | ||||
| Linear T-arm | ||||
| Movement | 500 mm | 500 mm | Same | |
| Range of | ||||
| Swing-arm | ||||
| Rotation | ± 12.5° | ± 15° | Wider | |
| Range of Stay- | ||||
| arm Rotation | 360° | 190° | ||
| Collimator | Collimator | Motor control / rotation | Motor control / rotation | Same |
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LIVERMORETECH
801 North JupiterRd, Suite 200, Plano, TX 70574 USA
Tel.: +214-257-0113
6
| Subject Device | Subject Device | Subject Device | Reference Device | ||
|---|---|---|---|---|---|
| Model | VIVIX-D | ||||
| 1212G | Pixium® Surgical | ||||
| 3030S-A | 3030DXV | VIVIX-D | |||
| 1212G | |||||
| 510(k) No | K180473 | K182086 | K132904 | K180473 | |
| Detector type | TFT | TFT | TFT | TFT | |
| Active detector size | 12 x 12 in | 12 x 12 in | 12 x 12 in | 12 x 12 in | |
| Total pixel matrix | 2048 x 2048 | 1956 x 1956 | 1536 x 1536 | 2048 x 2048 | |
| Pixel pitch | 145 μm | 154.0 μm | 194.0 μm | 145 μm | |
| Frame rate | 30 fps @ 2x2 | 30 fps | 30 fps | 30 fps @ 2x2 | |
| MTF | 1.0 lp/mm | 60% | 55% | 55% | 60% |
| DQE | 0 lp/mm | 69% | 75% | 80% | 69% |
FPD Image Detector Comparison
VII. Discussion of differences
The indications for use, operating principle, technical specifications such as X-ray tube head, image intensifier and FPD of FLUSION-9001 fluoroscopic C-arm Mobile X-ray System are similar to those of the predicate device (K032761) and reference device (K180473). FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System is designed as a set of components (X-ray tube and housing, detector, digital imaging system, collimator, generator etc.) similar to the predicate device KMC-950 (K032761). All digital flat panel detectors available for the subject device have been cleared by FDA as a part of a complete fluoroscopy system (K180473, K182086, K132904). Based on the recognized standard conformity evidences related to electro-, mechanical-, software-, and risk management, Livermoretech certifies that technological characteristics of FLUSION-9001 fluoroscopic C-arm Mobile X-ray System are substantially equivalent to KMC-950, the predicate device. FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System consists of many critical parts same as KMC-950, the predicate device (Collimator, X-ray imager, digital image processing and viewing program, C arm, etc.).
FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System utilizes PVCARM Viewer, a radiological digital image communications system. It provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions related to simple manipulation, enhancement or quantification of images.
-
PVCARM receives images from a detector, processes and transfers the images and manages patient's information and the images for doctor. PVCARM enables images such as x-ray images to be stored electronically and viewed on screens.
-
PVCARM offers full compliance with DICOM (Digital Imaging and Communications in Medicine) standards to allow the sharing of medical information with other PACS (Picture Archiving and Communication System Server).
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Tel.: +214-257-0113
VIII. Non clinical testing
Testing was performed successfully according to the following standards:
- EN 60601-1:2006/A1:2013 ●
- EN 60601-1-2:2015 (IEC 60601-1-2: 2014) ●
- IEC 60601-1-3:2008+A1:2013 ●
- IEC 60601-2-43:2010 ●
- IEC 60601-2-54:2009 + A1::2015 ●
Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients:
- "The Content of Premarket Submissions for Software Contained in Medical Devices" ●
- "Guidance for the Submission of 510(k) for Solid State X-ray Imaging devices" ●
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ● Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014
- Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.
All applicable aspects of these guidance documents listed in this 510(k) summary have been addressed.
The device also conforms to the following:
- 21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products ●
- 21 CFR 1020.30: Diagnostic x-ray system and their major components ●
- 21 CFR 1020.32: Fluoroscopic Equipment ●
IX. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided above comparison table, the FLUSION-9001 Fluoroscopic C-arm Mobile Xray System has little difference with its size and user interface as the information in the table. But the system is substantially equivalent to the predicate devices with its design, mechanical and electrical performance as described.
Performance evaluation (test) reports and device inspection report confirmed that the FLUSION-9001 Fluoroscopic C-arm Mobile X-ray System is suitable for its intended use and user instruction of the device.