Demetra Analytics Toolkit
FDA 510(k) clearance K201408 · decided 2021-02-18
Clearance details
- K-number
- K201408
- Device name
- Demetra Analytics Toolkit
- Applicant
- Barco N.V.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-28
- Decision date
- 2021-02-18
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- PSN
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kortrijk, BE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Barco N.V.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DeepX DermoSight Dermatoscope (K230448) | Deepx Health, LLC | 2023-05-17 |
| Demetra Dermatoscope BDEM-01 (K213957) | Barco N.V. | 2022-03-11 |
| Demetra BDEM-01 Dermatoscope (K192829) | Barco N.V. | 2019-12-13 |
| VivaScope System (K180162) | Caliber Imaging & Diagnostics, Inc. | 2018-05-03 |
| VIVASCOPE SYSTEM, MODEL 1500, 3000 (K080788) | Lucid, Inc. | 2008-09-17 |
| SIASCOPE V (K062736) | Astron Clinica Limited | 2007-09-14 |
| MICRODERM, MODEL/VERSION 3.5 (K040171) | Visiomed AG | 2004-06-08 |
| SIASCOPE II (K023729) | Astron Clinica Limited | 2003-02-03 |
| SI ASCOPE (K011273) | Astron Clinica Limited | 2002-02-20 |
Recalls involving this device
No recalls on record reference this clearance.