Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1760](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1760) → ITY — Assembly, Tube Housing, X-Ray, Diagnostic # ITY · Assembly, Tube Housing, X-Ray, Diagnostic _Radiology · 21 CFR 892.1760 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY ## Overview - **Product Code:** ITY - **Device Name:** Assembly, Tube Housing, X-Ray, Diagnostic - **Regulation:** [21 CFR 892.1760](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1760) - **Device Class:** 1 - **Review Panel:** [Radiology](/submissions/RA) ## Identification A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components. ## 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 | | --- | --- | --- | --- | --- | | [K000052](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K000052.md) | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | Dynarad Corp. | Feb 10, 2000 | SESE | | [K933162](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K933162.md) | MRX-750 | Mrx Corp. | Oct 7, 1993 | SESE | | [K923094](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K923094.md) | MOLYBDENUM | Southeastern Medical Diagnostics, Inc. | Mar 4, 1993 | SESE | | [K923141](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K923141.md) | PHILIPS PRE-FILTER OPTION | Philips Medical Systems, Inc. | Jan 21, 1993 | SESE | | [K921129](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K921129.md) | MRX-700 | Mrx-Ray Tube Corp. | Oct 5, 1992 | SESE | | [K921130](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K921130.md) | MRX-865 | Mrx-Ray Tube Corp. | Sep 10, 1992 | SESE | | [K921316](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K921316.md) | MG-1001 TUBE HOUSING ASSEMBLY | Magma Corp. | Jun 22, 1992 | SESE | | [K920731](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K920731.md) | X-RAY TUBE ASSEMBLY CIRCLEX1.2UG | Shimadzu Medical Systems | May 29, 1992 | SESE | | [K920724](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K920724.md) | HIGH SPEED ROTATION STARTER SA-50 | Shimadzu Medical Systems | Apr 27, 1992 | SESE | | [K920723](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K920723.md) | HIGH SPEED ROTATION STARTER SA-40 | Shimadzu Medical Systems | Apr 27, 1992 | SESE | | [K920387](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K920387.md) | CIRCLEXO.3T X-RAY TUBE ASSEMBLY | Shimadzu Medical Systems | Apr 14, 1992 | SESE | | [K913987](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K913987.md) | OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID | Codman & Shurtleff, Inc. | Apr 13, 1992 | SESE | | [K913301](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K913301.md) | MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM | Comet North America, Inc. | Aug 28, 1991 | SESE | | [K912338](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K912338.md) | TUBE HOUSING ASSEMBLIES | Comet Ltd. C/O Radiology Resources, Inc. | Aug 7, 1991 | SESE | | [K911695](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K911695.md) | VARIOUS X-RAY TUBES | Comet Ltd. C/O Radiology Resources, Inc. | Jun 19, 1991 | SESE | | [K910308](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K910308.md) | X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 | Inmark Corp. | Mar 27, 1991 | SESE | | [K910842](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K910842.md) | DI2000/HS-45-150 X-RAY TUBE INSERT | Comet Ltd. C/O Radiology Resources, Inc. | Mar 6, 1991 | SESE | | [K910276](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K910276.md) | X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 | Inmark Corp. | Mar 6, 1991 | SESE | | [K904182](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K904182.md) | R-800-SF | Advantech | Nov 13, 1990 | SESE | | [K900367](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K900367.md) | HOFMANN-NAGEL (HOFNA) X-RAY TUBES | Hofmann | Feb 26, 1990 | SESE | ## Top Applicants - Shimadzu Medical Systems — 4 clearances - Inmark Corp. — 4 clearances - X-Ray Tube Corp. — 3 clearances - Comet Ltd. C/O Radiology Resources, Inc. — 3 clearances - Siemens Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com