510(k) K041638
- Device
- TARGETSCAN BIOPSY KIT
- Applicant
- Envisioneering, LLC
- 510(k) number
- K041638
- Product code
- ITX
- Decision
- Unknown (SESK)
- Decision date
- 2004-09-02
- Date received
- 2004-06-17
- 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
- Yes
Applicant Contact#
- Contact
- TOM KAPPEL
- Address
- 1982 Innerbelt Business Ctr Dr. St. Louis MO US 63114 63114
FDA Registration Numbers#
- 3016096098
- 1000589001
- 3004485675
- 3016842138
- 9610482
- 3016854601
- 3010432890
- 3013181568
- 9614698
- 3008223664
- 2011171
- 3012981490
- 3006116468
- 3010258456
- 3015806723
- 9610877
- 1018233
- 3032807464
- 3011050570
- 1000314502
- 3026405201
- 3031851875
- 3009715136
- 3037874486
- 3003925093
- 3024673
- 8030607
- 3016171942
- 3040391009
- 1417592
- 3023245
- 1000601180
- 3011648943
- 9710388
- 3016696283
- 3038718997
- 1225687
- 3009156722
- 3012428212
- 1450908
- 3010827261
- 3012494290
- 3009435759
- 3012811961
- 3011599810
- 2939520
- 3014134519
- 3009988302
- 3003782610
- 3012939903
- 2918630
- 3042254626
- 3005877899
- 3012198618
- 1643817
- 1047843
- 9613994
- 3003851073
- 1319660
- 1066427
- 3045019904
- 2134265
- 3010193531
- 3044744649
- 3033527241
- 3013844297
- 3003995932
- 3032367
- 1224842
- 1220477
- 3006597338
- 9610595
- 3009656988
- 3003681187
- 8030392
- 3013764800
- 3012038665
- 3042470731
- 3008132411
- 2030624
Source Documents#
Other 510(k) Records For Product Code ITX#
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|---|---|---|---|
| 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 |