510(k) K190049
- Device
- Sim&Size
- Applicant
- Sim&Cure
- 510(k) number
- K190049
- Product code
- PZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-17
- Date received
- 2019-01-10
- Regulation
- 892.2050
- Classification name
- Software For Visualization Of Vascular Anatomy And Intravascular Devices
- Medical specialty
- Radiology
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Krishna Mahadea
- Address
- 1682 Rue De La Valsiere Grabels FR 34790 34790
FDA Registration Numbers#
- 3015978024
- 3038611208
- 3011205675
Source Documents#
Other 510(k) Records For Product Code PZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253122 | Sim&Size | Sim&Cure | 2025-12-23 |
| K250160 | ANKYRAS | Mentice Spain S.L. | 2025-05-06 |
| K242124 | Sim&Size | Sim&Cure | 2024-12-14 |
| K230006 | Ankyras | Mentice Spain S.L. | 2023-12-28 |
| K222664 | Sim&Size | Sim&Cure | 2023-01-27 |
| K213838 | AneuGuide | ArteryFlow Technology Co., Ltd. | 2022-06-01 |
| K212373 | Sim&Size | Sim&Cure | 2022-01-27 |
| K202322 | Sim&Size | Sim&Cure | 2020-12-31 |
| K171534 | SurgicalPreview | Endo Vantage, LLC | 2017-11-08 |
Legacy Summary#
summary
FDA Review#
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