Trimax Radiographic Cassette
FDA 510(k) K980722 · Imation Corp.
510(k) numberK980722
Submission
- Device name
- Trimax Radiographic Cassette
- Applicant
- Imation Corp.
Oakdale, MN, US - Received
- February 24, 1998
- Decision date
- March 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IXA
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|---|---|---|---|
| K081557 | Portable Supine Patient Support and Cassette HolderIXA · Traditional | Jddb Manufacturing, Inc. | 09/10/2008SE |
| K053173 | DS CassetteIXA · Traditional | Konica Minolta Medical & Graphic, Inc. | 12/15/2005SE |
| K040378 | Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253IXA · Traditional | Eastman Kodak Company | 05/24/2004SE |
| K023020 | Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and…IXA · Traditional | Agfa Corp. | 09/26/2002SE |
| K021903 | Kodak X-Omat Cassette/Leadless for Dental UseIXA · Special | Eastman Kodak Company | 07/10/2002SE |
| K013686 | Kodak Directview Tabletop CassetteIXA · Special | Eastman Kodak Company | 12/07/2001SE |
| K013229 | Liferay FW Mammo Cassette, Liferay KW Mammo CasetteIXA · Traditional | Ferrania USA, Inc. | 10/12/2001SE |
| K012373 | Liferay WL Cassette, Liferay KW CassetteIXA · Traditional | Ferrania S.P.A. | 08/09/2001SE |
| K983918 | Radiolucent Cassette Limb Positioner (R-Clip)IXA · Traditional | Mastek, Inc. | 03/12/1999SE |
| K963914 | CM & CM DS-7IXA · Traditional | Konica Medical Corp. | 10/08/1997SE |
More from Konica Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K984252 | Imation Trimatic Digital SystemLMA · Traditional | 01/25/1999SE |
| K973303 | Imation Model 9410 Network InterfaceLMD · Traditional | 11/25/1997SE |
| K972163 | Imation SE-196 Laser ImagerLMC · Traditional | 09/05/1997SE |
| K962750 | 3M Trimatic Modular Advanced Processing System and 3M Aps Automatic Film ProcessorIXW · Traditional | 08/21/1996SE |
Questions and answers
When was Trimax Radiographic Cassette cleared by the FDA?
Trimax Radiographic Cassette (K980722) received a 510(k) decision of Substantially Equivalent on March 23, 1998, 27 days after the submission was received.
What is the product code of K980722?
The FDA product code is IXA – Cassette, Radiographic Film, a Class II (moderate risk) device regulated under 21 CFR 892.1850.