510(k) K993674
- Device
- POCKET ULTRASONIC PACHYMETER
- Applicant
- QUANTEL MEDICAL
- 510(k) number
- K993674
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-07-13
- Date received
- 1999-11-01
- 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
- No
Applicant Contact#
- Contact
- GEORGE MYERS
- Address
- 377 Rte. 17s Hasbrouck Heights NJ US 07604 07604
FDA Registration Numbers#
- 1650907
- 3015972810
- 1528028
- 3012081348
- 3017944270
- 3004574050
- 3012761544
- 3019784575
- 3012204368
- 3013944123
- 8010047
- 3021226419
- 3014574557
- 3017263724
- 2011171
- 3004485675
- 3010102386
- 3010258456
- 1319660
- 3011763071
- 3005636544
- 3017697447
- 3029744051
- 3033710058
- 3005099803
- 3008548323
- 3011686611
- 3014745562
- 3008921662
- 3017406171
- 2134265
- 3005406110
- 3013840437
- 9680671
- 3024838922
- 3009600098
- 3003832357
- 3016493665
- 3016436764
- 3005877899
- 3006597338
- 3008363989
- 3006581049
- 1222780
- 3008487708
- 3005334138
- 3008496839
- 3009196578
- 2918630
- 3003412859
- 3004977335
- 3016171942
- 3007836437
- 3017968993
- 3019216
- 1000391004
- 2212018
- 3012747207
- 3031259044
- 9613249
- 2518897
- 3040391009
- 2320762
- 3014302721
- 3011162972
- 3012939903
- 9615439
- 9617592
- 2434141
- 3016854601
- 3003899230
- 3003681187
- 3006260740
- 3016096098
- 8043933
- 3034286426
- 3025786376
- 3016076141
- 2031044
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#
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