510(k) K181594 ยท OBO Tomography, Optical Coherence
Spectralis HRA+OCT and variants with OCT Angiography Module
| Applicant | Heidelberg Engineering GmbH, Heidelberg, DE |
| Decision | Substantially Equivalent, Sep 13, 2018 |
| Received | Jun 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181594
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Heidelberg Engineering GmbH 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 t Open, Classified |
OBO | None listed |
| Jul 3, 2019 | Heidelberg Engineering GmbH SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device. Terminated |
OBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.