SIASCOPE V
FDA 510(k) clearance K062736 · decided 2007-09-14
Clearance details
- K-number
- K062736
- Device name
- SIASCOPE V
- Applicant
- Astron Clinica Limited
- Decision
- Substantially Equivalent
- Date received
- 2006-09-13
- Decision date
- 2007-09-14
- Days to decision
- 366 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
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
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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 Analytics Toolkit (K201408) | Barco N.V. | 2021-02-18 |
| 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 |
| 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.