FDA UDI
In Commercial Distribution
🇺🇸 United States
Claire OCT System
DI: 00754016215056
·
Model: ASY-3220
·
Perimeter Medical Imaging AI, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Claire OCT System
- Primary DI
- 00754016215056
- Version / Model
- ASY-3220
- 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
- 2026-04-08
- Public Version
- 1
- Public Version Date
- 2026-04-16
- Public Version Status
- New
- Public Device Record Key
- cda97990-85e1-4ee8-9964-0db6873b3c30
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 |
|---|---|---|---|---|
| SHH | Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer | Unknown | 3 |
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 |
|---|---|---|---|---|---|---|
| Package | 10754016215053 | GS1 | Crate | 1 | In Commercial Distribution | |
| Primary | 00754016215056 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P250008 | 000 |