Spectralis HRA+OCT and variants with OCT Angiography Module— 510(k) K181594
Substantially EquivalentHeidelberg Engineering GmbH
FDA 510(k) clearance K181594 for Spectralis HRA+OCT and variants with OCT Angiography Module, Substantially Equivalent on 2018-09-13. Applicant: Heidelberg Engineering GmbH. Device class: 2.
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
view allMore clearances from Heidelberg Engineering GmbH
view allRecalls naming K181594
K-number listed on FDA's recall record- Z-3215-2026 — Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye
- Z-2437-2019 — SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181594.
Data sourced from openFDA. This site is unofficial and independent of the FDA.