Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1700](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1700) → IZO — Generator, High-Voltage, X-Ray, Diagnostic # IZO · Generator, High-Voltage, X-Ray, Diagnostic _Radiology · 21 CFR 892.1700 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO ## Overview - **Product Code:** IZO - **Device Name:** Generator, High-Voltage, X-Ray, Diagnostic - **Regulation:** [21 CFR 892.1700](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1700) - **Device Class:** 1 - **Review Panel:** [Radiology](/submissions/RA) ## Identification A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. This generic type of device may include a converter that changes alternating current to direct current, filament transformers for the x-ray tube, high voltage switches, electrical protective devices, or other appropriate elements. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. ## Recent Cleared Devices (20 of 163) Showing 20 most recent of 163 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K954666](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K954666.md) | MPH50, MPH65, AND MPH80 | GE Medical Systems | Nov 24, 1995 | SESE | | [K953582](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K953582.md) | HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR | Varian Canada, Inc. | Sep 26, 1995 | SESE | | [K953831](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K953831.md) | N 800 HF | Nucletron-Oldelft Corp. | Sep 8, 1995 | SESE | | [K952822](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K952822.md) | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G | Shimadzu Corp. | Jul 12, 1995 | SESE | | [K952265](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K952265.md) | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | Jul 6, 1995 | SESE | | [K950883](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K950883.md) | POLYDOROS SX 65 AND 80 | Siemens Medical Solutions USA, Inc. | Apr 3, 1995 | SESE | | [K950694](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K950694.md) | COMPACT-X | Electromed Intl., Ltd. | Mar 31, 1995 | SESE | | [K950291](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K950291.md) | DIGITAL 625HF | Fischer Imaging Corp. | Mar 23, 1995 | SESE | | [K950041](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K950041.md) | SII 360 APR | Scott Imaging Intl., Inc. | Mar 21, 1995 | SESE | | [K950040](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K950040.md) | SII 525 APR | Scott Imaging Intl., Inc. | Mar 21, 1995 | SESE | | [K945453](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K945453.md) | UD 150L-R II | Shimadzu Medical Systems | Mar 21, 1995 | SESE | | [K945452](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K945452.md) | UD 150L-F | Shimadzu Medical Systems | Mar 21, 1995 | SESE | | [K950037](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K950037.md) | N 800 HF | Oldelft Corp. of America | Feb 15, 1995 | SESE | | [K945731](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K945731.md) | HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS | Bennett X-Ray Corp. | Feb 15, 1995 | SESE | | [K945668](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K945668.md) | KXO-80G | Toshiba America Medical Systems, In.C | Dec 27, 1994 | SESE | | [K942731](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K942731.md) | SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR | Shimadzu Corp. | Oct 13, 1994 | SESE | | [K944150](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K944150.md) | MICRO X-65 HF | Fischer Imaging Corp. | Sep 16, 1994 | SESE | | [K944149](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K944149.md) | MICRO X-80 HF | Fischer Imaging Corp. | Sep 16, 1994 | SESE | | [K944148](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K944148.md) | MICRO X-30HF | Fischer Imaging Corp. | Sep 16, 1994 | SESE | | [K944147](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K944147.md) | MICRO X-50 HF | Fischer Imaging Corp. | Sep 16, 1994 | SESE | ## Top Applicants - Fischer Imaging Corp. — 22 clearances - General Electric Co. — 12 clearances - Shimadzu Medical Systems — 10 clearances - Electromed Intl., Ltd. — 8 clearances - Siemens Corp. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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