Emprint Visualization Application
by Covidien llc
510(k) K192038
Emprint Visualization Application is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Covidien llc, cleared under FDA 510(k) K192038 on 2 Dec 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192038 | Date2 Dec 2019 | StatusActive |
Official records
- FDA 510(k) database K192038
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Covidien, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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