ZEISS CLINIC 360— 510(k) K260694
Substantially EquivalentCarl Zeiss Meditec, AG
FDA 510(k) clearance K260694 for ZEISS CLINIC 360, Substantially Equivalent on 2026-07-17. Applicant: Carl Zeiss Meditec, AG. Device class: 2.
Summary
Carl Zeiss Meditec's ZEISS CLINIC 360 is filed under NFJ, ophthalmic image management systems. The record doesn't describe what the system does beyond that code name.
Class II, 21 CFR 892.2050. The Ophthalmic review panel handled it as a Traditional 510(k), though the record lists Radiology as the classification panel.
Carl Zeiss Meditec filed from Jena, Germany. Review took 136 calendar days (March 3 to July 17, 2026).
Clearance details
- Applicant
- Carl Zeiss Meditec, AG
- Product code
- Product code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jena, DE
Recent devices under product code NFJ
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