Vitrea Software Toshiba Package VSTP-001A
FDA 510(k) K173088 · Toshibamedical Systems Corporation
510(k) numberK173088
Submission
- Device name
- Vitrea Software Toshiba Package VSTP-001A
- Applicant
- Toshibamedical Systems Corporation
Otawara-Shi, JP - Received
- September 29, 2017
- Decision date
- January 31, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
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| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
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More from Avara Software
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| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemIYN · Traditional | 04/20/2018SE |
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| K173382 | Vantage Galan 3T, V4.6LNH · Traditional | 01/26/2018SE |
| K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4IYN · Traditional | 01/11/2018SE |
| K172863 | Infinix-i, INFX-8000V, V7.0OWB · Traditional | 12/14/2017SE |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0IYN · Traditional | 12/12/2017SE |
| K172646 | XIDF-AWS801, Angio Workstation, V7.0OWB · Traditional | 10/30/2017SE |
| K171597 | Vantage Elan 1.5T, V4.0LNH · Traditional | 07/21/2017SE |
| K170832 | Ultimax-i, DREX-UI80 V1.60OWB · Traditional | 07/21/2017SE |
| K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1JAK · Traditional | 06/30/2017SE |
Questions and answers
When was Vitrea Software Toshiba Package VSTP-001A cleared by the FDA?
Vitrea Software Toshiba Package VSTP-001A (K173088) received a 510(k) decision of Substantially Equivalent on January 31, 2018, 124 days after the submission was received.
What is the product code of K173088?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.