Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1860](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1860) → KPX — Changer, Radiographic Film/Cassette # KPX · Changer, Radiographic Film/Cassette _Radiology · 21 CFR 892.1860 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX ## Overview - **Product Code:** KPX - **Device Name:** Changer, Radiographic Film/Cassette - **Regulation:** [21 CFR 892.1860](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1860) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) ## Identification A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure. ## 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 the limitations in § 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 the limitations in § 892.9. ## Recent Cleared Devices (20 of 26) Showing 20 most recent of 26 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K945635](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K945635.md) | TRANS X-1000 | Canon USA, Inc. | Feb 1, 1995 | SESE | | [K935157](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K935157.md) | ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES | Regulatory Consultants TO the Medical Device Indus | Aug 9, 1994 | SESE | | [K934850](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K934850.md) | NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS | Victoreen, Inc. | Nov 22, 1993 | SESE | | [K933035](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K933035.md) | BCM-600TX | B C Medical , Ltd. | Oct 8, 1993 | SESE | | [K925598](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K925598.md) | BUCKYMATIC AUTOMATIC CHEST FILM CHANGER | Acoma Medical Imaging, Inc. | Feb 1, 1993 | SESE | | [K924423](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K924423.md) | MWX-7440 HIGH SPEED BUCKY | Midwest X-Ray Equipment Co. | Jan 15, 1993 | SESE | | [K925169](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K925169.md) | SHIMADZU RADIOGRAPJHIC STAND BR-100 | Shimadzu Medical Systems | Dec 3, 1992 | SESE | | [K920196](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K920196.md) | OX-600 | Stardard X-Ray Sales Co. | Oct 14, 1992 | SESE | | [K922483](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K922483.md) | DU PONT COMPACT DAYLIGHT SYSTEM 2000 | E.I. Dupont DE Nemours & Co., Inc. | Sep 11, 1992 | SESE | | [K905789](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K905789.md) | FRANKLIN 9000 WALL STAND | Mallinckrodt Group, Inc. | May 20, 1991 | SESE | | [K902761](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K902761.md) | AUTOMATIC CASSETTE LOADER | Mallinckrodt Group, Inc. | Oct 9, 1990 | SESE | | [K903576](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K903576.md) | PUCK 90M | Elema-Schonander, Inc. | Sep 4, 1990 | SESE | | [K870048](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K870048.md) | ADDITIONAL MODEL TO CANON UNIVERSAL STAND | Canon USA, Inc. | Jan 12, 1987 | SESE | | [K862575](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K862575.md) | UNIVERSAL STAND FOR FILM CHANGER | Canon USA, Inc. | Jul 14, 1986 | SESE | | [K853928](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K853928.md) | UNIVERSAL STAND FOR FILM CHANGER | Canon USA, Inc. | Oct 28, 1985 | SESE | | [K851067](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K851067.md) | CANON X-RAY FILM CHANGER CFC-U1 | Canon USA, Inc. | May 21, 1985 | SESE | | [K842911](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K842911.md) | PUCK U & UD CUTFILM CHANGERS | Elema-Schonander, Inc. | Aug 21, 1984 | SESE | | [K820117](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K820117.md) | AUTOMATIC TRAY (ACT I & ACT II | Burbury & Cutter Ind., Inc. | Feb 18, 1982 | SESE | | [K812024](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K812024.md) | XEROX 128 CASSETTE CHANGER | Xerox Medical Systems | Aug 13, 1981 | SESE | | [K811967](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K811967.md) | CP-625 SEE-THRU FILM CHANGER | Philips Medical Systems (Cleveland), Inc. | Aug 13, 1981 | SESE | ## Top Applicants - Canon USA, Inc. — 5 clearances - Mallinckrodt Group, Inc. — 4 clearances - Elema-Schonander, Inc. — 2 clearances - B C Medical , Ltd. — 2 clearances - Xerox Medical Systems — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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