FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Anterion
K Number: K230897
·
Decision Oct 11, 2023
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
62
Applicant Total
14
Review Days
194
Basic Information
- Device Name
- Anterion
- K Number
- K230897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heidelberg Engineering GmbH
- Date Received
- March 31, 2023
- Decision Date
- October 11, 2023
- Product Code
- OBO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | FDA class 2 | Ophthalmic |
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| K Number | Device Name | ||
|---|---|---|---|
| K250868 | SPECTRALIS HRA+OCT and variants | May 12, 2025 | Substantially Equivalent |
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| K240221 | SPECTRALIS HRA+OCT and variants | Jul 1, 2024 | Substantially Equivalent |
| K223557 | SPECTRALIS HRA+OCT and variants | Oct 20, 2023 | Substantially Equivalent |
| K211817 | Anterion | Nov 5, 2021 | Substantially Equivalent |
| K201252 | Spectralis HRA+OCT and variants | Sep 9, 2020 | Substantially Equivalent |
| K192391 | Spectralis HRA+OCT and Variants | Sep 26, 2019 | Substantially Equivalent |
| K182569 | Spectralis HRA+OCT and variants with High Magnification Module | Oct 18, 2018 | Substantially Equivalent |
| K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | Sep 13, 2018 | Substantially Equivalent |