510(k) K993624
- Device
- SITE-RITE 3 ULTRASOUND SYSTEM
- Applicant
- DYMAX CORP.
- 510(k) number
- K993624
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-11-10
- Date received
- 1999-10-26
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- CHARLES MORREALE
- Address
- 271 Kappa Dr. Pittsburgh PA US 15238 15238
FDA Registration Numbers#
- 3010398867
- 3003681187
- 8043933
- 3045030482
- 2936921
- 1222780
- 3031397684
- 3003647374
- 3009212453
- 3034232408
- 3025786376
- 3004569406
- 3029906632
- 3010034260
- 3032008018
- 3011050570
- 8020021
- 3038718997
- 2025099
- 9610632
- 3007695959
- 1000314502
- 3011416394
- 3044744649
- 3010610157
- 3015551113
- 3003857828
- 3011763071
- 1043214
- 3003412859
- 3009715136
- 3011686611
- 1450908
- 3005636544
- 2133641
- 3039935725
- 3008515880
- 3026405201
- 3014432311
- 2032350
- 3010102386
- 3014680735
- 2244725
- 1720929
- 3008386005
- 3010952312
- 1000391004
- 2531475
- 1528028
- 9611665
- 3025429169
- 3012761544
- 3014745562
- 1319660
- 3012204368
- 3002807715
- 3015973732
- 3013436538
- 3013844297
- 2212018
- 3015806723
- 3005875675
- 2124215
- 3012081348
- 3007738736
- 2024024
- 3013515803
- 3007740628
- 2518586
- 3006330030
- 3031259044
- 3017263724
- 1012187
- 3017697447
- 3032109181
- 3016171942
- 3005785090
- 3004485675
- 3012747207
Source Documents#
Other 510(k) Records For Product Code IYO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026-07-24 |
| K260190 | ARTHUR | ROPCA ApS | 2026-06-18 |
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | 2026-04-17 |
| K254021 | Accuro XV | Rivanna Medical, Inc. | 2026-04-09 |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | 2026-03-04 |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026-02-24 |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | 2026-02-06 |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | 2025-09-30 |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | 2025-08-01 |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | 2025-06-26 |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025-05-23 |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025-04-23 |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | 2024-11-19 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases