Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1980](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1980) → KXJ — Table, Radiologic # KXJ · Table, Radiologic _Radiology · 21 CFR 892.1980 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ ## Overview - **Product Code:** KXJ - **Device Name:** Table, Radiologic - **Regulation:** [21 CFR 892.1980](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1980) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) ## Identification A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9. ## Recent Cleared Devices (20 of 31) Showing 20 most recent of 31 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K050190](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K050190.md) | APOLLO | Villa Sistemi Medicali S.P.A. | Mar 25, 2005 | SESE | | [K963905](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K963905.md) | RADIOGRAPHIC ITT TABLE | X-Ray Technologies, Inc. | Nov 12, 1996 | SESE | | [K955414](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K955414.md) | XRT 400 | Wuestec Medical, Inc. | Jul 24, 1996 | SESE | | [K951146](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K951146.md) | IMAGING TABLE | Septa Corp. | May 4, 1995 | SESE | | [K950068](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K950068.md) | CARBON FIBER COUCH INSERT | Medtec, Inc. | Apr 6, 1995 | SESE | | [K950442](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K950442.md) | INFRARED EXPOSURE HAND SWITCH | Medical X-Ray Intl., Inc. | Mar 31, 1995 | SESE | | [K940696](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K940696.md) | SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 | Philips Medical Systems North America, Inc. | Mar 16, 1994 | SESE | | [K931724](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K931724.md) | ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES | Continental X-Ray Corp. | Jun 14, 1993 | SESE | | [K926407](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K926407.md) | MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM | Nucletron-Oldelft Corp. | Mar 31, 1993 | SESE | | [K922098](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K922098.md) | CAG-02A | Toshiba America Medical Systems, In.C | Jul 27, 1992 | SESE | | [K913121](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K913121.md) | OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 | Continental X-Ray Corp. | Aug 16, 1991 | SESE | | [K883885](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K883885.md) | RADKOR, RF-159 | Radkor, Inc. | Oct 19, 1988 | SESE | | [K883155](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K883155.md) | RASTIX X-RAY TABLE | Bay X-Ray, Inc. | Sep 6, 1988 | SESE | | [K881700](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K881700.md) | RADKOR KOB-84 | Radkor, Inc. | Sep 2, 1988 | SESE | | [K874934](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K874934.md) | UNIVERSAL EXAMINATION TABLE | Imatron, Inc. | Jan 19, 1988 | SESE | | [K874639](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K874639.md) | REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100 | Shimadzu Precision Instruments, Inc. | Dec 4, 1987 | SESE | | [K871827](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K871827.md) | OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER | General Electric Co. | Jun 19, 1987 | SESE | | [K862144](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K862144.md) | X-MAT | Combined Concepts, Inc. | Jun 25, 1986 | SESE | | [K860620](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K860620.md) | SHAMPAINE RADI-OP MODEL 1700RC | Smith & Nephew, Inc. | Apr 8, 1986 | SESE | | [K854328](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ/K854328.md) | MEDEX X-RAY TABLE | Philips Medical Systems (Cleveland), Inc. | Jan 28, 1986 | SESE | ## Top Applicants - Siemens Corp. — 3 clearances - Radkor, Inc. — 2 clearances - Philips Medical Systems (Cleveland), Inc. — 2 clearances - Continental X-Ray Corp. — 2 clearances - X-Ray Technologies, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KXJ) **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