510(k) K920882
- Device
- ACUSON V714 TRANSDUCER
- Applicant
- ACUSON CORP.
- 510(k) number
- K920882
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-03-26
- Date received
- 1992-02-26
- Regulation
- 892.1570
- Classification name
- Transducer, Ultrasonic, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHEILA PICKERING
- Address
- 1220 Charleston Rd. Mountain View CA US 94039 94039
FDA Registration Numbers#
- 3004987887
- 3007994837
- 8043933
- 3014279513
- 3003594449
- 2134812
- 3010432890
- 3013368530
- 3008321254
- 3011137372
- 3005403518
- 3016096098
- 3032109181
- 1450908
- 3042585081
- 1045254
- 3018781093
- 2938651
- 3009756153
- 3014134519
- 3011392709
- 2954783
- 3043226252
- 3008487708
- 3016171942
- 1055823
- 3010663777
- 3017406171
- 8030392
- 1820334
- 3033858858
- 1720929
- 3009499478
- 3008223664
- 3010457937
- 3003899230
- 3008386005
- 3013764800
- 3013443304
- 3010760216
- 3017968993
- 3012811961
- 3043012240
- 3009156722
- 3031397684
- 3021970996
- 3010220244
- 3014755924
- 3005334138
- 3017636737
- 3012402886
- 1450662
- 3016696283
- 3016842138
- 3008627763
- 3021226419
- 3029916061
- 1037885
- 9610482
- 2939520
- 2011171
- 3012494290
- 3010082909
- 3011763071
- 3015806723
- 3014769442
- 3006330030
- 3012939903
- 3009565060
- 3031158
- 3012127758
- 1417592
- 3006985147
- 1000601180
- 1319660
- 3006979678
- 9680794
- 1224842
- 3003412859
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | 2026-09-24 |
| K261170 | BA-004CC | Fujifilm Corporation | 2026-08-12 |
| K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | 2026-08-10 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases