510(k) K111157
- Device
- CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, And GANGLION CELL NORMATIVE DATABASES
- Applicant
- CARL ZEISS MEDITEC INC
- 510(k) number
- K111157
- Product code
- OBO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-01-19
- Date received
- 2011-04-25
- Regulation
- 886.1570
- Classification name
- Tomography, Optical Coherence
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUDITH A BRIMACOMBE
- Address
- 5160 Hacienda Dr. Dublin CA US 94568 94568
FDA Registration Numbers#
- 3004441848
- 9611269
- 3005950902
- 3033566
- 9616199
- 9614661
- 3038356864
- 3005744933
- 3038614464
- 8030392
- 2242863
- 3006809695
- 9615010
- 9617167
- 1054713
- 9615030
- 3008348697
- 2936921
- 2918630
- 3002807715
- 3010000450
- 8043762
- 3013403214
- 3020723591
- 8020986
- 1000181430
- 3008729548
- 3004026651
- 3009746052
- 3003589956
Source Documents#
Other 510(k) Records For Product Code OBO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2026-05-07 |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | 2025-12-23 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | 2025-07-18 |
| K250868 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2025-05-12 |
| K240924 | Anterion | Heidelberg Engineering GmbH | 2024-12-13 |
| K241163 | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2024-10-11 |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024-07-17 |
| K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2024-07-01 |
| K233933 | CIRRUS™ HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. | 2024-05-17 |
| K233602 | P200TE (A10700) | Optos Plc. | 2024-05-09 |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024-04-10 |
| K233421 | RESCAN 700 | Carl Zeiss Meditec, AG | 2024-03-08 |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023-10-30 |
| K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2023-10-20 |
| K230897 | Anterion | Heidelberg Engineering GmbH | 2023-10-11 |
Legacy Summary#
summary
FDA Review#
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