(72 days)
No
The summary describes a standard C-Arm fluoroscopic/angiographic system focused on hardware and basic digital imaging capabilities, with no mention of AI or ML features.
No
The device is described as an imaging system used for diagnostic purposes, specifically to visualize anatomical structures and blood vessels, and for "diagnostic and therapeutic procedures requiring fluoroscopic and radiographic imaging," but not as a device that provides therapy itself.
Yes
The "Device Description" explicitly states that the system is "intended for angiographic and related diagnostic and therapeutic procedures".
No
The device description clearly outlines multiple hardware components including a C-Arm support, control electronics box, display panel, table-side control panel, high voltage generator, x-ray tube assembly, and a DSA system.
Based on the provided information, the Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for visualizing anatomical structures and blood vessels within the body using x-radiation and contrast medium. This is an in vivo (within the living organism) application, not in vitro (outside the living organism, typically on biological samples).
- Device Description: The description details a system for generating and capturing x-ray images of the patient's body. This aligns with imaging devices used directly on patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Hitachi SX-VA30 is a medical imaging device used for diagnostic and therapeutic procedures performed directly on patients, not an IVD.
N/A
Intended Use / Indications for Use
The Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System is intended to visualize anatomical structures by converting a pattern of xradiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
Product codes
892.1600
Device Description
The Hitachi SX-VA30 C-Arm Angiographic/Fluoroscopic System is a single plane, ceiling suspended C-Arm system intended for angiographic and related diagnostic and therapeutic procedures requiring fluoroscopic and radiographic imaging. It is configured with other components such as high voltage generator, x-ray tube assembly, DSA system, etc., to form a complete fluoroscopy and angiography system. The C-arm is disposed on the isocenter and is movable in a wide range to permit studies of the patient's whole body from the head to the foot from a number of angles.
The SX-VA30 system consists of the SX-VA30 Ceiling-traveling C-Arm Support with ceiling track rails, the control electronics box, the display panel, and the table-side control panel. The SX-VA30 is also configured with the DFA-100-30 digital subtraction angiography system, and several other components which have been previously cleared by FDA as a part of K945400.
While the system is configured with a digital imaging system as standard, conventional film radiography may be employed as an option.
In the digital domain, acquired images may be stored in a variety of formats. During acquisition cycles, the progress of the study can be monitored as it occurs, largely eliminating the need for studies to be redone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-radiation (X-ray)
Anatomical Site
Whole body (from head to foot), heart or blood vessels
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
The SX-VA30 was tested in the same manner as was the previously cleared SF-VA100. This testing addressed the following issues:
- (1) Electrical Safety
- (2) Conformance to the General Rules for Medical X-Ray Equipment. JIS Z 4701-1988 (Japanese Industrial Standard)
- (3) Conformance to the applicable provisions of the FDA Performance Standards for Ionizing Radiation Emitting Products (21 CFR 1020), particularly the section for Fluoroscopic Equipment (21 CFR 1020.32).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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510(k) Summary
Hitachi SX-VA30
Common/Classification Name: Angiographic X-ray System, 21 CFR 892.1600
Hitachi Medical Systems America, Inc. 1963 Case Parkway Twinsburg, OH 44087 216-425-1313, 216-425-1410 (FAX) Contact: John T. Newland, Prepared: November 26, 1996
LEGALLY MARKETED PREDICATE DEVICES A.
The Hitachi SX-VA30 C-Arm Angiographic/Fluoroscopic System is substantially equivalent to the presently marketed Hitachi SF-VA100 as distributed by Hitachi Medical Systems America (as cleared in K945400) and the Philips Medical Systems Integris V3000 (K923813). The SX-VA30 is manufactured by Hitachi Medical Corporation, Hitachi Hagoromo Building, 1-2-10 Uchi-Kanda, Chivoda-Ku, Tokyo, 101, Japan. This 510(k) is submitted because the SX-VA30 is a new device.
DEVICE DESCRIPTION B.
The Hitachi SX-VA30 C-Arm Angiographic/Fluoroscopic System is a single plane, ceiling suspended C-Arm system intended for angiographic and related diagnostic and therapeutic procedures requiring fluoroscopic and radiographic imaging. It is configured with other components such as high voltage generator, x-ray tube assembly, DSA system, etc., to form a complete fluoroscopy and angiography system. The C-arm is disposed on the isocenter and is movable in a wide range to permit studies of the patient's whole body from the head to the foot from a number of angles.
The SX-VA30 system consists of the SX-VA30 Ceiling-traveling C-Arm Support with ceiling track rails, the control electronics box, the display panel, and the table-side control panel. The SX-VA30 is also configured with the DFA-100-30 digital subtraction angiography system, and several other components which have been previously cleared by FDA as a part of K945400.
While the system is configured with a digital imaging system as
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standard, conventional film radiography may be employed as an option.
In the digital domain, acquired images may be stored in a variety of formats. During acquisition cycles, the progress of the study can be monitored as it occurs, largely eliminating the need for studies to be redone.
INTENDED USE C.
The Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System is intended to visualize anatomical structures by converting a pattern of xradiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Hitachi SX-VA30 has the same intended use and target population as the predicate devices, and has equivalent effectiveness for its intended use.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics of the Hitachi SX-VA30 are the same as for the Philips Integris V3000 C-Arm system, and except for the support system, are the same as for the SF-VA100.
Subsystem components such as X-ray generators, X-ray tubes, X-ray columnators and receptors, and digital processing systems are identical or very similar to the corresponding components of the SF-VA100.
Most of the differences between the predicate devices and the SX-VA30 are in areas of incremental improvements and have been gained using technology common to both designs.
F. TESTING
The SX-VA30 was tested in the same manner as was the previously cleared SF-VA100. This testing addressed the following issues:
- (1) Electrical Safety:
- (2) Conformance to the General Rules for Medical X-Ray Equipment. JIS Z 4701-1988 (Japanese Industrial Standard); and
- (3) Conformance to the applicable provisions of the FDA Performance
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Standards for Ionizing Radiation Emitting Products (21 CFR 1020), particularly the section for Fluoroscopic Equipment (21 CFR 1020.32).
G. CONCLUSIONS
Hitachi Medical Systems America has demonstrated that the Hitachi SX-VA30 is substantially equivalent to the Hitachi SF-VA100 and the Philips Integris V3000.
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