510(k) K080119
- Device
- CLEARSCAN
- Applicant
- ESI, INC.
- 510(k) number
- K080119
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-02-21
- Date received
- 2008-01-17
- 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
- No
Applicant Contact#
- Contact
- GEORGE MYERS
- Address
- 377 Rte. 17s Hasbrouck Heights NJ US 07604 07604
FDA Registration Numbers#
- 3010398867
- 3003681187
- 8043933
- 9616515
- 3045030482
- 2936921
- 1222780
- 3031397684
- 3003647374
- 3009212453
- 3034232408
- 3025786376
- 3032008018
- 3011050570
- 8020021
- 3038718997
- 3007695959
- 1000314502
- 3011416394
- 3044744649
- 3006854672
- 8043385
- 2528981
- 3010610157
- 3013595964
- 3004727093
- 3008177921
- 3011274144
- 3011763071
- 3018094310
- 1043214
- 3003412859
- 3009715136
- 3011686611
- 1061927
- 1450908
- 3005636544
- 3003637092
- 3039935725
- 3008515880
- 3026405201
- 3010389834
- 3014432311
- 2032350
- 3010102386
- 3014680735
- 3010188783
- 1720929
- 3010060157
- 3008386005
- 3010952312
- 1000391004
- 2531475
- 9616086
- 1528028
- 1000393132
- 9611665
- 3025429169
- 3012761544
- 3014745562
- 1319660
- 1000589001
- 3002807715
- 3013436538
- 3006116468
- 3013844297
- 3015806723
- 3005875675
- 3017884667
- 2124215
- 3012081348
- 3007738736
- 2024024
- 3013515803
- 3007740628
- 3009490946
- 2518586
- 3006330030
- 3031259044
- 3017263724
Source Documents#
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |
Legacy Summary#
summary
FDA Review#
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