FDA Registration
Active
🇺🇸 United States
CLEERLY, INC
Reg #: 3017167291
·
FEI: 3017167291
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- CLEERLY, INC
- Registration Number
- 3017167291
- FEI Number
- 3017167291
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1099 18th Street, Suite 2860
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242338
Owner / Operator
- Firm Name
- Cleerly, Inc
- Operator Number
- 10076670
- Address
- 1099 18th street, Suite 2860
- City
- Denver
- State
- CO
- Postal Code
- 80202
- Country
- US
- Correspondent
- Amit Relia
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-03-25 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-03-25 |
| Adjunctive Epicardial Vascular Physiologic Status Indicator | QXZ | Class 2 | Cardiovascular | No | 2023-09-21 |
Proprietary Names
Cleerly LABS (v2)
Cleerly Ischemia
Cleerly Coronary; Cleerly Labs v2
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198