Arterys Software v2.0
by Arterys Inc.
510(k) K162513
Arterys Software v2.0 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Arterys Inc., cleared under FDA 510(k) K162513 on 28 Oct 2016, 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 | NumberK162513 | Date28 Oct 2016 | StatusActive |
Official records
- FDA 510(k) database K162513
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Arterys, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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