IXA · Cassette, Radiographic Film
Radiology · 21 CFR 892.1850 · Class 2
Overview
| Product Code | IXA |
|---|---|
| Device Name | Cassette, Radiographic Film |
| Regulation | 21 CFR 892.1850 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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 | PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER | Jddb Manufacturing, Inc. | Sep 10, 2008 | SESE |
| K053173 | DS CASSETTE | Konica Minolta Medical & Graphic, Inc. | Dec 15, 2005 | SESE |
| K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | Eastman Kodak Company | May 24, 2004 | SESE |
| K023020 | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE | Agfa Corp. | Sep 26, 2002 | SESE |
| K021903 | KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE | Eastman Kodak Company | Jul 10, 2002 | SESE |
| K013686 | KODAK DIRECTVIEW TABLETOP CASSETTE | Eastman Kodak Company | Dec 7, 2001 | SESE |
| K013229 | LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE | Ferrania USA, Inc. | Oct 12, 2001 | SESE |
| K012373 | LIFERAY WL CASSETTE, LIFERAY KW CASSETTE | Ferrania S.P.A. | Aug 9, 2001 | SESE |
| K983918 | RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) | Mastek, Inc. | Mar 12, 1999 | SESE |
| K980722 | TRIMAX RADIOGRAPHIC CASSETTE | Imation Corp. | Mar 23, 1998 | SESE |
| K963914 | CM & CM DS-7 | Konica Medical Corp. | Oct 8, 1997 | SESE |
| K971431 | UMI X-RAY FILM CASSETTE | Umi Intl. | May 20, 1997 | SESE |
| K970090 | SOLO-SLED | Solo-Sled, LLC | Apr 21, 1997 | SESE |
| K961453 | KODAK MN-R 2000 CASSETTE | Eastman Kodak Company | Jul 25, 1996 | SESE |
| K962336 | RADIOGRAPHIC FILM CASSETTES | Unidex Group, Inc. | Jul 3, 1996 | SESE |
| K953725 | CRONEX RADIATION THERAPY VERIFICATION CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | Sep 6, 1995 | SESE |
| K953724 | CRONEX RADIATION THERAPY CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | Sep 6, 1995 | SESE |
| K953444 | MCI OPTONIX ECONOMY CASSETTE | Mci Optonix, Inc. | Aug 2, 1995 | SESE |
| K952891 | CRONEX LOW ABSORPTION CASSETTE | The DU Pont Co. | Jul 13, 1995 | SESE |
| K951006 | 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
