SIMSYS
Basic Information
- Brand Name
- SIMSYS
- Primary DI
- 00628451918073
- Version / Model
- V
- Company Name
- MedX Health Corp
- Labeler DUNS
- 202128257
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2018-10-17
- Public Version Status
- Update
- Public Device Record Key
- b5737861-751d-40c2-be11-b3dd72deeb6c
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PSN | Light Based Imaging | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32696 | Skin transilluminator, battery-powered | A hand-held, battery-powered device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628451918073 | GS1 | ||||
| Direct Marking | 00628451918004 | GS1 | ||||
| Package | 10628451918070 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1 905 670 4428
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062736 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius