FDA UDI
In Commercial Distribution
🇺🇸 United States
THiA
DI: 00754016215018
·
Model: PMI001OCT21
·
Perimeter Medical Imaging AI, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- THiA
- Primary DI
- 00754016215018
- Version / Model
- PMI001OCT21
- Catalog Number
- ASY-2000
- Company Name
- Perimeter Medical Imaging AI, Inc.
- Labeler DUNS
- 204112346
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-30
- Public Version
- 2
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- 37731bb2-5f6f-472f-bc63-0fa17767eb91
Device Description
The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58074 | Dermatological optical coherence tomography system | An assembly of devices designed to use a broad-bandwidth light beam aimed via an applicator at a region of interest (ROI) on the surface of the skin for optical coherence tomography (OCT) to provide high-resolution images (e.g., above 1 micron) of the surface tissue in order to visualize skin morphology. It typically consists of a main unit with an operator's console, a computer for image storage, a hand-held or electromechanical probe (applicator), and a visual display unit (VDU). Reflected light is picked up by the probe that converts it into electrical signals. The computer and dedicated software provide cross-sectional images of the derma or two- or three-dimensional (3-D) volume scans. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00754016215018 | GS1 | ||||
| Package | 10754016215015 | GS1 | Single unit package | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-877-278-4614
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203578 | 000 |