510(k) K091877
- Device
- CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL
- Applicant
- CHISON MEDICAL IMAGING CO., LTD.
- 510(k) number
- K091877
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-09-02
- Date received
- 2009-06-23
- 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
- BOB LEIKER
- Address
- 7263 Cronin Cir. Dublin CA US 94568 94568
FDA Registration Numbers#
- 3003412859
- 8043933
- 3010398867
- 3006082230
- 1826555
- 3026405201
- 2183319
- 3016171942
- 3005636544
- 3045030482
- 3010400367
- 8030607
- 3012811961
- 3013944123
- 3009482034
- 1643817
- 3027501622
- 3008950127
- 3015972810
- 3006540052
- 2221819
- 3010273872
- 3003832357
- 9680794
- 3014605202
- 3014639846
- 8020021
- 3025429169
- 1450908
- 8010047
- 3001763079
- 3021226419
- 3014432311
- 3013595964
- 3002807715
- 3024673
- 3034286426
- 2183744
- 3008729547
- 2936921
- 3012198618
- 9710090
- 1047843
- 3004753388
- 3017487805
- 3011392709
- 3016076141
- 9613067
- 3004181533
- 3011416394
- 3014574557
- 3007544634
- 3024838922
- 3011200896
- 3006382185
- 2433682
- 3042225166
- 3006265099
- 3016493665
- 3013757696
- 3017968993
- 1126271
- 3037874486
- 3014279513
- 3014134519
- 3015972753
- 3003681187
- 3004987887
- 3012761544
- 3011686611
- 9610877
- 3008627763
- 3009499478
- 1224842
- 3010258456
- 2032350
- 1000269286
- 3033858858
- 3004035727
- 3003925093
Source Documents#
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#
summary
FDA Review#
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