Kalare
FDA 510(k) K133553 · Toshiba America Medical Systems, In.C
510(k) numberK133553
Submission
- Device name
- Kalare
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- November 19, 2013
- Decision date
- June 13, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242488 | Soteria E-ViewJAA · Traditional | Omega Medical Imaging, LLC | 01/06/2025SE |
| K242948 | Adora DRFi (04550010)JAA · Traditional | Nrt X-Ray A/S | 12/23/2024SE |
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| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special | Philips Medical Systems Dmc GmbH | 01/11/2024SE |
| K232910 | CombiDiagnost R90JAA · Special | Philips Medical Systems Dmc GmbH | 10/19/2023SE |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA · Special | Canon Medical Systems Corporation | 09/12/2023SE |
| K220871 | NautilusJAA · Special | Dornier Medtech America, Inc. | 04/18/2022SE |
| K212890 | Nyquist.IQJAA · Traditional | Omega Medical Imaging, LLC | 12/13/2021SE |
More from Omega Medical Imaging, LLC
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| K132106 | Infinix Angio Workstation W/Dts SoftwareJAA · Traditional | 11/12/2013SE |
| K131822 | Ultraextend USWS-900A V2.1 and V3.1LLZ · Traditional | 07/23/2013SE |
| K123097 | Dose Tracking System Model XIDF-DTS801JAA · Traditional | 02/13/2013SE |
| K122613 | Vantage Titan with Helios Gradient Model MRT-1504/USLNH · Traditional | 12/13/2012SE |
| K122842 | Radrex-I, SW V4.00 Model DRAD-3000EMQB · Special | 10/09/2012SE |
| K121076 | Ultraextend FX, Ultrasound Workstation PackageLLZ · Traditional | 10/09/2012SE |
| K122109 | Aquilion One Vision, V4.90JAK · Traditional | 09/21/2012SE |
| K112989 | Aquilion CXLJAK · Traditional | 04/10/2012SE |
Questions and answers
When was Kalare cleared by the FDA?
Kalare (K133553) received a 510(k) decision of Substantially Equivalent on June 13, 2014, 206 days after the submission was received.
What is the product code of K133553?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.