510(k) K930278
- Device
- STORZ COMPUSCAN AB
- Applicant
- STORZ
- 510(k) number
- K930278
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-09
- Date received
- 1993-01-21
- 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
- MICHAEL T TAGGART
- Address
- 3365 Tree Ct. Industrial Boulevard St. Louis MO US 63122 63122
FDA Registration Numbers#
- 3007994837
- 8043933
- 3014279513
- 3003594449
- 2134812
- 3008321254
- 3011137372
- 3005403518
- 1721686
- 3016096098
- 3032109181
- 1450908
- 3042585081
- 9611343
- 3009756153
- 3014134519
- 2184149
- 2954783
- 3008487708
- 3016171942
- 9614587
- 3010663777
- 3003857828
- 3017406171
- 8030392
- 3015551113
- 2320762
- 3033858858
- 1720929
- 3009499478
- 3008223664
- 3010457937
- 3003899230
- 1834003
- 3008386005
- 3013764800
- 3010760216
- 3017968993
- 3012811961
- 3009156722
- 3031397684
- 3021970996
- 2244725
- 3010220244
- 3004569406
- 3014755924
- 3005334138
- 3017636737
- 3012402886
- 3016696283
- 1450662
- 3016842138
- 2212018
- 3021226419
- 3029916061
- 9610482
- 1055236
- 2939520
- 2011171
- 3012494290
- 3010082909
- 3011763071
- 3015806723
- 3006330030
- 9610632
- 1061124
- 3012939903
- 3009565060
- 3031158
- 3012127758
- 3006985147
- 1000601180
- 1319660
- 3006979678
- 9680794
- 1224842
- 3015506965
- 3003412859
- 3008363989
Source Documents#
Other 510(k) Records For Product Code IYO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261648 | Evident Vascular™ Guidance System | Evident Vascular, Inc. | 2026-10-28 |
| K262093 | Accuro XV | Rivanna Medical, Inc. | 2026-10-20 |
| K260605 | Lilium one (USM330) | Lilium Otsuka Co., Ltd. | 2026-10-16 |
| K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | 2026-09-24 |
| 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 |
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