Olinda Exm
FDA 510(k) K163687 · Hermes Medical Solutions AB
510(k) numberK163687
Submission
- Device name
- Olinda Exm
- Applicant
- Hermes Medical Solutions AB
Stockholm, SE - Received
- December 28, 2016
- Decision date
- July 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K191216 | Voxel Dosimetry v1.0LLZ · Traditional | 10/17/2019SE |
| K181468 | Hybrid3DKPS · Traditional | 10/25/2018SE |
| K171719 | Hybrid3DKPS · Traditional | 11/21/2017SE |
| K171681 | Hermes Medical Imaging Suite v5.7KPS · Traditional | 11/21/2017SE |
Questions and answers
When was Olinda Exm cleared by the FDA?
Olinda Exm (K163687) received a 510(k) decision of Substantially Equivalent on July 19, 2017, 203 days after the submission was received.
What is the product code of K163687?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.