510(k) K993978
- Device
- PR3 ULTRASOUND SYSTEM
- Applicant
- CAROLINA MEDICAL, INC.
- 510(k) number
- K993978
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-02-10
- Date received
- 1999-11-24
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARROLL L TURNER
- Address
- 157 Industrial Dr. King NC US 27021 27021
FDA Registration Numbers#
- 3005406110
- 3008487708
- 3008729547
- 2518897
- 3003589956
- 3017955833
- 2531475
- 3008506949
- 3010663777
- 9617592
- 2521877
- 3009435759
- 2025099
- 3013535906
- 3018884581
- 3010390468
- 3026047529
- 3002808148
- 3009156722
- 9680579
- 3027501622
- 3006786907
- 3010400367
- 3011692238
- 9615439
- 3012198618
- 3011278898
- 3007740628
- 3008548323
- 9610816
- 3011162972
- 3011050570
- 3003971136
- 3013844297
- 3003647374
- 8020021
- 3007015148
- 3007994837
- 3031564213
- 3007603826
- 3025786376
- 3008223664
- 8043817
- 3035950510
- 3010760216
- 3010082909
- 3015506965
- 3014809646
- 3009077524
- 3011416394
- 3029937167
- 3026405201
- 3007562060
- 2030624
- 3031259044
- 3010933511
- 1043214
- 3004574050
- 3031823165
- 3047889344
- 2031044
- 3006597338
- 2522950
- 1226587
- 3035373446
- 1047843
- 3042585081
- 3012387143
- 3029916061
- 1126271
- 3010220595
- 3040391009
- 3005877899
- 3009758186
- 3006110251
- 9610632
- 2029275
- 3011106828
- 2134265
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IYO #
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|---|---|---|---|
| K262093 | Accuro XV | Rivanna Medical, Inc. | 2026-10-20 |
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| 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 |
Legacy Summary#
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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