510(k) K254143
- Device
- EM-TECH Passive Ultrasound Probe Strap
- Applicant
- EM-TECH Solutions, Inc.
- 510(k) number
- K254143
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-10
- Date received
- 2025-12-22
- Regulation
- 892.1570
- Classification name
- Transducer, Ultrasonic, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Enayatullah Motahedy
- Address
- 25272 Mcintyre Sq. Chantilly VA US 20152 20152
FDA Registration Numbers#
- 1650907
- 3013429557
- 3015972810
- 1528028
- 3012081348
- 1820334
- 3017944270
- 3004574050
- 3012761544
- 3019784575
- 3013557562
- 3003623887
- 3013944123
- 3013181568
- 3006082230
- 8010047
- 3021226419
- 3003925093
- 3014574557
- 9613994
- 3017263724
- 2011171
- 3009286597
- 3004485675
- 3010102386
- 9680135
- 3010258456
- 1319660
- 3011763071
- 3005636544
- 3029744051
- 3005099803
- 9611680
- 3008548323
- 3011686611
- 9616515
- 2528981
- 3014745562
- 3008921662
- 3017406171
- 2134265
- 3005406110
- 9680671
- 3027788423
- 3024838922
- 3010188783
- 3003832357
- 3016493665
- 3016436764
- 3005877899
- 1416980
- 3013368530
- 3018094310
- 3006597338
- 9616086
- 3008177921
- 3008363989
- 1222780
- 3008487708
- 3005334138
- 3008496839
- 3009196578
- 3011392709
- 2020394
- 2918630
- 3003412859
- 1018233
- 3016171942
- 3007836437
- 1000589001
- 3017968993
- 3019216
- 3006265099
- 1836161
- 1000391004
- 3012316249
- 3012747207
- 3031259044
- 2518897
- 3040391009
Source Documents#
Other 510(k) Records For Product Code ITX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261170 | BA-004CC | Fujifilm Corporation | 2026-08-12 |
| K260161 | SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. | 2026-07-30 |
| K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026-07-27 |
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2026-07-24 |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | 2025-09-18 |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation | 2025-07-11 |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | 2025-07-02 |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2025-06-13 |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | 2024-08-30 |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | 2024-08-15 |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2024-07-03 |
| K233109 | TP Pivot Pro™ Needle Guide | Civco Medical Solutions | 2023-12-22 |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | 2023-12-13 |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |
| K223689 | Disposable Needle Guides and Grids | Advance Medical Designs, Inc. | 2023-08-02 |