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#
- 3017140456
- 3006597338
- 3010220244
- 3008496839
- 3003832357
- 3019216
- 1055823
- 9617592
- 2954783
- 3032008018
- 3007994837
- 3015525240
- 3016171942
- 3010188783
- 3010082909
- 3005860720
- 2031044
- 3025786376
- 3011200896
- 9680671
- 3038718997
- 3003637092
- 3002315840
- 1319660
- 3043011436
- 3011106828
- 3012939903
- 3008640801
- 3013727803
- 1000391004
- 3010041511
- 3034286426
- 9710388
- 3010381606
- 3012981490
- 3027501622
- 3017263724
- 1319639
- 2246552
- 1222780
- 3004987887
- 3005334138
- 3008177921
- 9610482
- 3003782610
- 3011416394
- 3015136743
- 3013443304
- 2030624
- 3017884667
- 3010102386
- 3012198618
- 1720929
- 1037885
- 3006110251
- 9611125
- 2950776
- 3005877899
- 3024673
- 3009756153
- 3014639846
- 3033858858
- 3014432311
- 3005810333
- 1820334
- 3009988302
- 3034232408
- 3010398867
- 1528028
- 3004009431
- 3014421917
- 3001763079
- 3003681187
- 9614641
- 3009656988
- 3029744051
- 9680135
- 3004530184
- 3037874486
Source Documents#
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2023-01-11 |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022-11-22 |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | 2022-06-07 |
Legacy Summary#
summary
FDA Review#
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