Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1850](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1850) → IXA — Cassette, Radiographic Film # IXA · Cassette, Radiographic Film _Radiology · 21 CFR 892.1850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA ## Overview - **Product Code:** IXA - **Device Name:** Cassette, Radiographic Film - **Regulation:** [21 CFR 892.1850](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1850) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) ## Identification A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. ## 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 51) Showing 20 most recent of 51 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K081557](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K081557.md) | PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER | Jddb Manufacturing, Inc. | Sep 10, 2008 | SESE | | [K053173](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K053173.md) | DS CASSETTE | Konica Minolta Medical & Graphic, Inc. | Dec 15, 2005 | SESE | | [K040378](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K040378.md) | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | Eastman Kodak Company | May 24, 2004 | SESE | | [K023020](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K023020.md) | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE | Agfa Corp. | Sep 26, 2002 | SESE | | [K021903](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K021903.md) | KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE | Eastman Kodak Company | Jul 10, 2002 | SESE | | [K013686](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K013686.md) | KODAK DIRECTVIEW TABLETOP CASSETTE | Eastman Kodak Company | Dec 7, 2001 | SESE | | [K013229](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K013229.md) | LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE | Ferrania USA, Inc. | Oct 12, 2001 | SESE | | [K012373](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K012373.md) | LIFERAY WL CASSETTE, LIFERAY KW CASSETTE | Ferrania S.P.A. | Aug 9, 2001 | SESE | | [K983918](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K983918.md) | RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) | Mastek, Inc. | Mar 12, 1999 | SESE | | [K980722](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K980722.md) | TRIMAX RADIOGRAPHIC CASSETTE | Imation Corp. | Mar 23, 1998 | SESE | | [K963914](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K963914.md) | CM & CM DS-7 | Konica Medical Corp. | Oct 8, 1997 | SESE | | [K971431](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K971431.md) | UMI X-RAY FILM CASSETTE | Umi Intl. | May 20, 1997 | SESE | | [K970090](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K970090.md) | SOLO-SLED | Solo-Sled, LLC | Apr 21, 1997 | SESE | | [K961453](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K961453.md) | KODAK MN-R 2000 CASSETTE | Eastman Kodak Company | Jul 25, 1996 | SESE | | [K962336](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K962336.md) | RADIOGRAPHIC FILM CASSETTES | Unidex Group, Inc. | Jul 3, 1996 | SESE | | [K953725](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K953725.md) | CRONEX RADIATION THERAPY VERIFICATION CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | Sep 6, 1995 | SESE | | [K953724](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K953724.md) | CRONEX RADIATION THERAPY CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | Sep 6, 1995 | SESE | | [K953444](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K953444.md) | MCI OPTONIX ECONOMY CASSETTE | Mci Optonix, Inc. | Aug 2, 1995 | SESE | | [K952891](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K952891.md) | CRONEX LOW ABSORPTION CASSETTE | The DU Pont Co. | Jul 13, 1995 | SESE | | [K951006](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K951006.md) | KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) | Kenex , Ltd. | Apr 3, 1995 | SESE | ## Top Applicants - Eastman Kodak Company — 13 clearances - E.I. Dupont DE Nemours & Co., Inc. — 6 clearances - Mci Optonix, Inc. — 2 clearances - Fujifilm Medical System U.S.A., Inc. — 2 clearances - Dupont Medical Products — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA) **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