510(k) K031571
- Device
- EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
- Applicant
- E-Z-EM, INC.
- 510(k) number
- K031571
- Product code
- IZQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-06-19
- Date received
- 2003-05-20
- Regulation
- 870.1650
- Classification name
- Injector, Contrast Medium, Automatic
- Medical specialty
- Cardiovascular
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN HARTMAN
- Address
- 717 Main St. Westbury NY US 11590 11590
FDA Registration Numbers#
- 1518293
- 3006617533
- 3011816507
- 3040111919
- 3011334555
- 3004753774
- 2520313
- 3002807314
- 3012044688
- 3009882464
- 3010374357
- 3003366417
- 1054713
- 1319639
- 3002808022
- 3012529833
- 3030656768
- 3010659128
- 2029275
- 1018470
- 3005441393
- 8020864
- 3010173425
- 1038185
- 3004050971
- 9612420
- 9616567
- 3009756327
- 3010155661
- 3006791331
- 3010160527
- 3002806603
- 3004056159
- 3003786696
- 3006174295
- 1000604079
- 2134243
- 3001427085
Source Documents#
Other 510(k) Records For Product Code IZQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | 2025-11-18 |
| K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | 2025-11-07 |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. | 2025-09-24 |
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. | 2024-11-05 |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | 2024-08-26 |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | 2024-04-19 |
| K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2021-08-06 |
| K192872 | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | 2020-07-02 |
| K171392 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2017-11-09 |
| K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set | Bracco Injeneering | 2016-01-22 |
| K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System | Liebel-Flarsheim Company, LLC | 2016-01-14 |
| K091734 | SONIC SHOT GX | Nemoto Kyorindo Co., Ltd. | 2010-05-21 |
| K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | Mallinckrodt Inc., Liebel-Flarsheim Business | 2007-04-27 |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | E-Z-Em, Inc. | 2007-04-13 |
| K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | Medrad, Inc. | 2007-03-27 |
Legacy Summary#
summary
FDA Review#
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