Isrobot Mona Lisa
FDA 510(k) K111347 · Biobot Surgical Pte., Ltd.
510(k) numberK111347
Submission
- Device name
- Isrobot Mona Lisa
- Applicant
- Biobot Surgical Pte., Ltd.
Alexandria, VA, US - Received
- May 13, 2011
- Decision date
- August 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Accutome, Inc. Doing Business AS Keeler USA
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|---|---|---|
| K232320 | iSR`obot Mona Lisa 2.0IYO · Special | 12/21/2023SE |
| K213411 | iSRobot Mona Lisa 2.0IYO · Traditional | 12/22/2021SE |
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| K163502 | iSR'obot Biopsy KitITX · Traditional | 05/16/2017SE |
| K161109 | iSR'obot MRI-US FusionLLZ · Traditional | 10/06/2016SE |
| K130944 | Isr'Obot Mona LisaIYO · Special | 06/07/2013SE |
Questions and answers
When was Isrobot Mona Lisa cleared by the FDA?
Isrobot Mona Lisa (K111347) received a 510(k) decision of Substantially Equivalent on August 12, 2011, 91 days after the submission was received.
What is the product code of K111347?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.