Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product Series
FDA 510(k) K071378 · E-Z-Em, Inc.
510(k) numberK071378
Submission
- Device name
- Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product Series
- Applicant
- E-Z-Em, Inc.
Westbury, NY, US - Received
- May 17, 2007
- Decision date
- June 13, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062449 | Empowermr Injector System, Model 9730IZQ · Abbreviated | 04/13/2007SE |
| K063029 | Empower Ct/Cta Injector System, Model 9800/9900JAK · Special | 11/02/2006SE |
| K053008 | E-Z-Em Endoscopic CO2 RegulatorFCX · Abbreviated | 12/27/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | 07/16/2004SE |
| K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825IZQ · Special | 06/19/2003SE |
| K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400FCX · Special | 04/16/2003SE |
| K013219 | PROTOCO2L Insufflator Model 6400FCX · Abbreviated | 02/19/2002SE |
| K011160 | E-Z Em Percupump 2001 CT InjectorJAK · Special | 05/16/2001SE |
| K974621 | Percupump II with EdaDSB · Traditional | 01/27/1998SE |
| K961845 | Percupump II with EdaDSB · Traditional | 01/23/1997SE |
Questions and answers
When was Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product Series cleared by the FDA?
Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product Series (K071378) received a 510(k) decision of Substantially Equivalent on June 13, 2007, 27 days after the submission was received.
What is the product code of K071378?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.