510(k) K080555
- Device
- SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
- Applicant
- IVU IMAGING CORPORATION
- 510(k) number
- K080555
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-03
- Date received
- 2008-02-28
- 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
- Yes
Applicant Contact#
- Contact
- MARK L STRIBLING
- Address
- 4121 Grace Ln. Grapevine TX US 76051 76051
FDA Registration Numbers#
- 3004727093
- 3011599810
- 9611680
- 3009435759
- 3011692238
- 1000601180
- 3019216
- 3002183074
- 3010952312
- 3042225166
- 3025786376
- 1066427
- 2020394
- 3008627763
- 3017884667
- 1226587
- 2025773
- 3013058729
- 3012761544
- 2518897
- 3010827261
- 3009756153
- 3016171942
- 2939520
- 3002808148
- 8043933
- 3014302721
- 3043012240
- 3015276088
- 9611033
- 3032807464
- 3011763071
- 2939830
- 3010389834
- 3009196578
- 1000269286
- 2134812
- 3004485675
- 2221819
- 3010305275
- 3011200896
- 3017487805
- 1930027
- 3013557562
- 3014574557
- 3017057763
- 1650907
- 3012316249
- 3010933511
- 3003589956
- 3007194257
- 1037885
- 3004753388
- 2433682
- 3006540052
- 9680794
- 3008363989
- 1836161
- 3031823165
- 3007603826
- 2183744
- 3014745562
- 3010220244
- 3007544634
- 3008595936
- 3011137372
- 3007740628
- 3013368530
- 3012428212
- 3015531959
- 3010703925
- 3012494290
- 9710090
- 1047843
- 3012987001
- 3031569584
- 1216677
- 3013595964
- 3003899230
- 2954783
Source Documents#
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K222460 | Intraoperative Ultrasound Probe Cover | Exact Medical Manufacturing | 2023-05-12 |
Legacy Summary#
summary
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