Heidelberg Retina Angiograph Fa/Icga (Hra/C)
FDA 510(k) K971671 · Heidelberg Engineering
510(k) numberK971671
Submission
- Device name
- Heidelberg Retina Angiograph Fa/Icga (Hra/C)
- Applicant
- Heidelberg Engineering
Heidelberg, DE - Received
- May 7, 1997
- Decision date
- July 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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| K240924 | AnterionOBO · Traditional | 12/13/2024SE |
| K241163 | SPECTRALIS with Flex ModuleOBO · Traditional | 10/11/2024SE |
| K240221 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | 07/01/2024SE |
| K223557 | SPECTRALIS HRA+OCT and variantsOBO · Traditional | 10/20/2023SE |
| K230897 | AnterionOBO · Traditional | 10/11/2023SE |
| K211817 | AnterionOBO · Traditional | 11/05/2021SE |
| K201252 | Spectralis HRA+OCT and variantsOBO · Traditional | 09/09/2020SE |
Questions and answers
When was Heidelberg Retina Angiograph Fa/Icga (Hra/C) cleared by the FDA?
Heidelberg Retina Angiograph Fa/Icga (Hra/C) (K971671) received a 510(k) decision of Substantially Equivalent on July 29, 1997, 83 days after the submission was received.
What is the product code of K971671?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.