← Product Code [JAA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA) · K964990 # HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) (K964990) _Hitachi Medical Systems America, Inc. · JAA · Feb 26, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K964990 ## Device Facts - **Applicant:** Hitachi Medical Systems America, Inc. - **Product Code:** [JAA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA.md) - **Decision Date:** Feb 26, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1650 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels. ## Device Story Ceiling-suspended single-plane C-arm system for angiographic/fluoroscopic imaging. Inputs: X-radiation patterns converted to electronic images. Components: High-voltage generator, X-ray tube, digital subtraction angiography (DSA) system, ceiling-traveling support, control electronics, display/table-side panels. Operation: C-arm rotates around isocenter for whole-body imaging (head to foot). Output: Real-time fluoroscopic/radiographic images displayed for clinician monitoring during procedures. Usage: Clinical setting (e.g., interventional suites); operated by physicians/technicians. Benefit: Enables visualization of anatomical structures and vasculature; real-time monitoring reduces need for repeat studies. ## Clinical Evidence Bench testing only. Compliance verified against electrical safety standards, JIS Z 4701-1988 (General Rules for Medical X-Ray Equipment), and FDA Performance Standards for Ionizing Radiation Emitting Products (21 CFR 1020), specifically 21 CFR 1020.32 for fluoroscopic equipment. ## Technological Characteristics Ceiling-suspended C-arm; X-ray imaging system. Components: High-voltage generator, X-ray tube, collimator, receptor, and digital processing system. Connectivity: Digital imaging system with optional conventional film radiography. Standards: JIS Z 4701-1988, 21 CFR 1020.32. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Hitachi SF-VA100 ([K945400](/device/K945400.md)) - Philips Medical Systems Integris V3000 ([K923813](/device/K923813.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FEB 26 1997 # 510(k) Summary K964990 # 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 ## A. LEGALLY MARKETED PREDICATE DEVICES 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, Chiyoda-Ku, Tokyo, 101, Japan. This 510(k) is submitted because the SX-VA30 is a new device. ## B. 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 000034 {1} 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. ## C. INTENDED USE The Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels. ## D. SUBSTANTIAL EQUIVALENCE SUMMARY The Hitachi SX-VA30 has the same intended use and target population as the predicate devices, and has equivalent effectiveness for its intended use. ## E. TECHNOLOGICAL CHARACTERISTICS 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 000035 {2} 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. 000036 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K964990](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K964990) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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