Identity
- Trade Name
- SIMSYS FDA UDI
- Generic Name
- Skin transilluminator, battery-powered FDA UDI
- Device Name
- The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit. Simsys is an image management system for the Siascope , which in addition to the features of the Molemate software, includes mole and lesion visualization and comprehensive patient image and data storage capabilities. FDA UDI
- Model / Reference
- V FDA UDI
- Description
- The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit. Simsys is an image management system for the Siascope , which in addition to the features of the Molemate software, includes mole and lesion visualization and comprehensive patient image and data storage capabilities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628451918073 FDA UDI
- 510(k) Number
- K062736 FDA UDI
- FDA Product Code
- PSN FDA UDI
- GMDN Term
- Skin transilluminator, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin transilluminator, battery-powered
Simsys by MedX Health Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin transilluminator, battery-powered.
- Venoscope — VENOSCOPE, LLC · Class I
- ASTODIA — Stihler Electronic GmbH · Class I
- Finhoff Transilluminator 2.8v — KEELER LIMITED · Class II
- Venoscope — VENOSCOPE, LLC · Class I
- MoleMate — MedX Health Corp · Class II
Cleared under the same submission
K062736 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MedX Health Corp
Sources (1)
- FDA UDI b5737861-751d-40c2-be11-b3dd72deeb6c 36 fields · synced Jun 6, 2026