CT-Modeller System
510(k) K970617
CT-Modeller System is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Materialise NV, cleared under FDA 510(k) K970617 on 21 Apr 1997, 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 | NumberK970617 | Date21 Apr 1997 | StatusActive |
Official records
- FDA 510(k) database K970617
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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