Kodak X-Omat Cassette/Leadless for Dental Use
FDA 510(k) K021903 · Eastman Kodak Company
510(k) numberK021903
Submission
- Device name
- Kodak X-Omat Cassette/Leadless for Dental Use
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- June 10, 2002
- Decision date
- July 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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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 |
| 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 |
| K980722 | Trimax Radiographic CassetteIXA · Traditional | Imation Corp. | 03/23/1998SE |
| K963914 | CM & CM DS-7IXA · Traditional | Konica Medical Corp. | 10/08/1997SE |
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| 510(k) | Device | Decision |
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| K060550 | Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386KPR · Special | 03/31/2006SE |
| K060137 | Kodak Eclipse Image Processing SoftwareMQB · Special | 03/16/2006SE |
| K060079 | Kodak Model CR-7400 Digital Radiography SystemMUH · Special | 02/08/2006SE |
| K060055 | Kodak PacsLLZ · Traditional | 02/07/2006SE |
| K053347 | Kodak Carestream PacsLLZ · Special | 01/04/2006SE |
| K051483 | Kodak Directview DR System DetectorMQB · Traditional | 06/21/2005SE |
| K051258 | Kodak Directview DR 7500 System, Model 8791345KPR · Special | 06/01/2005SE |
| K042159 | Kodak Color Medical Imager 1000LMC · Traditional | 09/24/2004SE |
| K042158 | Kodak Medical Imager 300LMC · Traditional | 09/24/2004SE |
| K040378 | Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253IXA · Traditional | 05/24/2004SE |
Questions and answers
When was Kodak X-Omat Cassette/Leadless for Dental Use cleared by the FDA?
Kodak X-Omat Cassette/Leadless for Dental Use (K021903) received a 510(k) decision of Substantially Equivalent on July 10, 2002, 30 days after the submission was received.
What is the product code of K021903?
The FDA product code is IXA – Cassette, Radiographic Film, a Class II (moderate risk) device regulated under 21 CFR 892.1850.