ANTERION— 510(k) K261019
Substantially EquivalentHeidelberg Engineering GmbH
FDA 510(k) clearance K261019 for ANTERION, Substantially Equivalent on 2026-09-11. Applicant: Heidelberg Engineering GmbH. Device class: 2.
Summary
ANTERION from Heidelberg Engineering is filed under OBO, optical coherence tomography. The code covers viewing, imaging, measurement, and analysis of ocular structures, as a diagnostic aid in detecting and managing ocular diseases. The record doesn't say which structures ANTERION images.
Class II, 21 CFR 886.1570. The Ophthalmic panel reviewed it as a Traditional 510(k).
Heidelberg Engineering filed from Heidelberg, Germany. Review took 168 days (March 27 to September 11, 2026).
Clearance details
- Applicant
- Heidelberg Engineering GmbH
- Product code
- Product code OBO
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Heidelberg, DE
Recent devices under product code OBO
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