Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253
FDA 510(k) K040378 · Eastman Kodak Company
510(k) numberK040378
Submission
- Device name
- Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- February 17, 2004
- Decision date
- May 24, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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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| 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 |
| K040556 | Trophypan C with Orthoimaging/Omsimaging AccessoryEHD · Special | 04/07/2004SE |
Questions and answers
When was Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253 cleared by the FDA?
Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253 (K040378) received a 510(k) decision of Substantially Equivalent on May 24, 2004, 97 days after the submission was received.
What is the product code of K040378?
The FDA product code is IXA – Cassette, Radiographic Film, a Class II (moderate risk) device regulated under 21 CFR 892.1850.