510(k) K963169
- Device
- RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL
- Applicant
- RAPID-AID LTD./LTEE
- 510(k) number
- K963169
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-12
- Date received
- 1996-08-14
- Regulation
- 892.1570
- Classification name
- Transducer, Ultrasonic, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE SCHMIDT
- Address
- 4-3345 Laird Rd. Mississuaga,Ontario CA L5L 5R6 L5L 5R6
FDA Registration Numbers#
- 3013844297
- 3005099803
- 3004705634
- 1450908
- 3013058729
- 1048735
- 1047843
- 3005860720
- 3033527283
- 3009656988
- 1650907
- 3012402886
- 3015972753
- 1319639
- 1528028
- 3012987001
- 1930027
- 3010060157
- 3009212453
- 3005785090
- 9615849
- 3014769442
- 3034232408
- 3031569584
- 3011200896
- 9613067
- 3013515803
- 3012038665
- 2221819
- 2938651
- 3042225166
- 3005810333
- 3043011436
- 3025429169
- 3015525240
- 1643817
- 3010102386
- 3011392709
- 3012104670
- 3003637092
- 8030392
- 3010381606
- 3010457937
- 3009293490
- 3003774756
- 3033275035
- 3007738736
- 9710388
- 1226587
- 3011396687
- 1820334
- 2531814
- 3010188783
- 3013595964
- 3008627763
- 3009490946
- 3012981490
- 3009499478
- 3012428212
- 3018094310
- 3043534483
- 2531475
- 1126271
- 3032367
- 1720929
- 3003681187
- 2522950
- 1417592
- 3013944123
- 8030607
- 1416980
- 3013727803
- 3010193531
- 2434141
- 3032109225
- 3006854672
- 3004181533
- 3019216
- 3006680097
- 1018233
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2023-01-11 |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022-11-22 |
Legacy Summary#
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FDA Review#
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