Empowermr Injector System, Model 9730
FDA 510(k) K062449 · E-Z-Em, Inc.
510(k) numberK062449
Submission
- Device name
- Empowermr Injector System, Model 9730
- Applicant
- E-Z-Em, Inc.
Westbury, NY, US - Received
- August 22, 2006
- Decision date
- April 13, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IZQ – Injector, Contrast Medium, Automatic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code IZQ
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|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery SystemIZQ · Traditional | ACIST Medical Systems, Inc. | 08/03/2026SE |
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 11/18/2025SE |
| K251295 | ulrichINJECT CT Motion (XD 8000)IZQ · Traditional | Ulrich GmbH & Co. KG | 11/07/2025SE |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Special | Imaxeon Pty, Ltd. | 09/24/2025SE |
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Traditional | Imaxeon Pty, Ltd. | 11/05/2024SE |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 08/26/2024SE |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 04/19/2024SE |
| K210541 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 08/06/2021SE |
| K192872 | ulrichINJECT CT MotionIZQ · Traditional | Ulrich GmbH & Co. KG | 07/02/2020SE |
| K171392 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 11/09/2017SE |
More from Ulrich GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K071378 | Modification to Empower Ct/Cta Injector System, Models 9800/9900 Product SeriesJAK · Special | 06/13/2007SE |
| 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 Empowermr Injector System, Model 9730 cleared by the FDA?
Empowermr Injector System, Model 9730 (K062449) received a 510(k) decision of Substantially Equivalent on April 13, 2007, 234 days after the submission was received.
What is the product code of K062449?
The FDA product code is IZQ – Injector, Contrast Medium, Automatic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.