Arterys Viewer
by Arterys Inc.
510(k) K171544
Arterys Viewer is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Arterys Inc., cleared under FDA 510(k) K171544 on 18 Jul 2017, 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 | NumberK171544 | Date18 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K171544
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- Withdrawn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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