Diagnostic Ultrasound/Uro-Gyn Ud 511
FDA 510(k) K911166 · Diagnostic Ultrasound Corp.
510(k) numberK911166
Submission
- Device name
- Diagnostic Ultrasound/Uro-Gyn Ud 511
- Applicant
- Diagnostic Ultrasound Corp.
Kirkland, WA, US - Received
- March 15, 1991
- Decision date
- August 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXT – Injector And Syringe, Angiographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code DXT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…DXT · Traditional | Fortis Biosolutions Company Limited | 05/14/2026SE |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeDXT · Traditional | Shenzhen Maiwei Biotech Co., Ltd. | 04/16/2026SE |
| K251788 | Extension tubeDXT · Traditional | Zhuhai DR Medical Instruments Co., Ltd. | 03/05/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | Bayer Medical Care, Inc. | 02/13/2026SE |
| K244038 | High Pressure TubingDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 09/05/2025SE |
| K242143 | Angiography InjectorDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 12/23/2024SE |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)DXT · Traditional | Nemoto Kyorindo Co., Ltd. | 08/27/2024SE |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and AccessoriesDXT · Traditional | Shenzhen Boon Medical Supply Co., Ltd. | 08/22/2024SE |
More from Shenzhen Boon Medical Supply Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K030763 | Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemIYO · Traditional | 03/26/2003SE |
| K022153 | Bladderscan Bvi 6100IYO · Traditional | 08/15/2002SE |
| K982568 | Bladdermanager Pci 5000 Model 1002ITX · Traditional | 01/25/1999SE |
| K963585 | Bladder Manager Pci 5000, Bladderscan Bvi 5000IYO · Traditional | 10/01/1996SE |
| K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000IYO · Traditional | 05/24/1996SE |
| K955942 | Bladderscan Bvi 5000IYO · Traditional | 03/15/1996SE |
| K920664 | Diagnostic Ultrasound/Uro-Gyn Ups 2020, Gi VersionFFX · Traditional | 12/23/1993SE |
| K915342 | Ud 2000 Video OptionLLZ · Traditional | 06/10/1992SE |
| K915436 | Bladderscan Bvi 2500IYO · Traditional | 03/03/1992SE |
| K911125 | Diagnostic Ultrasound/Uro-Gyn Ups 2020FAP · Traditional | 08/15/1991SE |
Questions and answers
When was Diagnostic Ultrasound/Uro-Gyn Ud 511 cleared by the FDA?
Diagnostic Ultrasound/Uro-Gyn Ud 511 (K911166) received a 510(k) decision of Substantially Equivalent on August 15, 1991, 153 days after the submission was received.
What is the product code of K911166?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.