CM & CM DS-7
FDA 510(k) K963914 · Konica Medical Corp.
510(k) numberK963914
Submission
- Device name
- CM & CM DS-7
- Applicant
- Konica Medical Corp.
New York, NY, US - Received
- September 30, 1996
- Decision date
- October 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IXA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K980722 | Trimax Radiographic CassetteIXA · Traditional | Imation Corp. | 03/23/1998SE |
More from Imation Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K990969 | Konica Srx- 701 Automatic X-Ray Film ProcessorIXW · Traditional | 06/18/1999SE |
| K963913 | MD100 & MM150EAM · Traditional | 10/08/1997SE |
| K955583 | VifsJAK · Traditional | 05/14/1996SE |
| K933830 | Konica LD-4500 Laser DigitizerLMA · Traditional | 12/14/1993SE |
| K931317 | Konica SRX-301 Automatic X-Ray Film ProcessorIXW · Traditional | 12/14/1993SE |
| K931316 | Konica DS-7 Automatic X-Ray Film ProcessorIXW · Traditional | 12/14/1993SE |
| K931315 | Konica SRX-501A Automatic X-Ray Film ProcessorIXW · Traditional | 12/14/1993SE |
| K931314 | Konica QX-70 Automatic X-Ray Film ProcessorIXW · Traditional | 09/07/1993SE |
| K931313 | Konica QX-130APLUS Automatic X-Ray Film ProcessorIXW · Traditional | 09/07/1993SE |
| K931312 | Konica SRX-101 Automatic X-Ray Film ProcessorIXW · Traditional | 09/07/1993SE |
Questions and answers
When was CM & CM DS-7 cleared by the FDA?
CM & CM DS-7 (K963914) received a 510(k) decision of Substantially Equivalent on October 8, 1997, 373 days after the submission was received.
What is the product code of K963914?
The FDA product code is IXA – Cassette, Radiographic Film, a Class II (moderate risk) device regulated under 21 CFR 892.1850.