K251532 is an FDA 510(k) clearance for the Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Mighty Oak Medical (Englewood, US). The FDA issued a Cleared decision on November 3, 2025, 168 days after receiving the submission on May 19, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K251532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2025 |
| Decision Date | November 03, 2025 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |