Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1770](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1770) → IYB — Tube Mount, X-Ray, Diagnostic # IYB · Tube Mount, X-Ray, Diagnostic _Radiology · 21 CFR 892.1770 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB ## Overview - **Product Code:** IYB - **Device Name:** Tube Mount, X-Ray, Diagnostic - **Regulation:** [21 CFR 892.1770](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1770) - **Device Class:** 1 - **Review Panel:** [Radiology](/submissions/RA) ## Identification A diagnostic x-ray tube mount is a device intended to support and to position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. ## 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 40) Showing 20 most recent of 40 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K935123](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K935123.md) | SUPERSTAND 300 | Wuestec Medical, Inc. | Mar 27, 1996 | SESE | | [K946261](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K946261.md) | MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 | Scott Imaging Intl., Inc. | Feb 15, 1995 | SESE | | [K941017](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K941017.md) | F/C/W TUBESTAND | Acoma Medical Imaging, Inc. | Jul 29, 1994 | SESE | | [K941004](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K941004.md) | CTS SYSTEM | Acoma Medical Imaging, Inc. | Jul 29, 1994 | SESE | | [K940442](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K940442.md) | MPR-814 | Xri, Inc. | Jun 9, 1994 | SESE | | [K935004](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K935004.md) | MODEL ALPHA TS-2 | Dpa Consulting, Inc. | Dec 13, 1993 | SESE | | [K933253](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K933253.md) | SUPERSTAND 3000 | Wuestec Medical, Inc. | Aug 16, 1993 | SESE | | [K925716](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K925716.md) | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | Bennett X-Ray Corp. | Dec 17, 1992 | SESE | | [K925170](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K925170.md) | SHIMADZU X-RAY TUBE STAND BH-100 SERIES | Shimadzu Medical Systems | Dec 7, 1992 | SESE | | [K920727](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K920727.md) | CEILING TUBE SUPPORT CH-30X | Shimadzu Medical Systems | Apr 16, 1992 | SESE | | [K914944](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K914944.md) | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC | Bennett X-Ray Corp. | Dec 2, 1991 | SESE | | [K914348](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K914348.md) | ER-1000 CATHERIZATION C-ARM SYSTEMS | Shimadzu Medical Systems | Nov 1, 1991 | SESE | | [K911563](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K911563.md) | INVENTOR RT/EXPLORER TRAUMA UNIT | Continental X-Ray Corp. | Oct 23, 1991 | SESE | | [K912696](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K912696.md) | TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL | Bennett X-Ray Corp. | Sep 16, 1991 | SESE | | [K900234](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K900234.md) | PFM-90 CEILING TUBE SUPPORT | Fischer Imaging Corp. | Feb 26, 1990 | SESE | | [K895188](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K895188.md) | SHIMADZU X-RAY TUBE STAND FH-31 | Shimadzu Medical Systems | Sep 22, 1989 | SESE | | [K893653](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K893653.md) | RADIOGRAPHIC CEILING TUBE SUPPORT CTS15 | Fischer Imaging Corp. | Jun 23, 1989 | SESE | | [K893652](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K893652.md) | RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60 | Fischer Imaging Corp. | Jun 23, 1989 | SESE | | [K883664](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K883664.md) | LUM VASCULAR PROCEDURE SYSTEM #B5200A | General Electric Co. | Nov 7, 1988 | SESE | | [K883864](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB/K883864.md) | RADKOR SFR-70 | Radkor, Inc. | Oct 19, 1988 | SESE | ## Top Applicants - Fischer Imaging Corp. — 5 clearances - Shimadzu Medical Systems — 4 clearances - Radkor, Inc. — 3 clearances - Bennett X-Ray Corp. — 3 clearances - Wuestec Medical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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