NFJ · System, Image Management, Ophthalmic

Device class

Class II

Regulation 892.2050

Total clearances

2020-03-03 → 2026-07-17

Last 12 months

Unique sponsors

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.2050

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Carl Zeiss Meditec, AG	4	1	2026-07-17
Topcon Healthcare Solutions	2	0	2023-11-20
Topcon Healthcare Solutions EMEA Oy	2	1	2026-06-04
Topcon Corporation	1	0	2024-03-01
Ophthalmic Labs, Inc.	1	0	2020-03-03
Konan Medical, Inc.	1	0	2021-06-15
Altris, Inc.	1	0	2023-07-31
Visionquest Biomedical, Inc.	1	0	2020-12-24
Canon, Inc.	1	0	2020-09-25
Centervue S.P.A.	1	0	2024-08-22
Retinai Medical AG	1	0	2022-04-28
Integrated Ophthalmic Systems, Inc.	1	0	2020-03-16
Merit Cro, Inc.	1	0	2022-10-31

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
92504	CPT	—	Low	Ophthalmic imaging may involve photography or diagnostic imaging, but coding is context-dependent

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-17	K260694	Carl Zeiss Meditec, AG	ZEISS CLINIC 360
2026-06-04	K253893	Topcon Healthcare Solutions EMEA Oy	Harmony Referral System with Harmony OCT Viewer (Octave)
2024-08-22	K234076	Centervue S.P.A.	iCare ALTIUS CW
2024-03-01	K232828	Topcon Corporation	IMAGEnet6 Ophthalmic Data System
2023-12-21	K232944	Carl Zeiss Meditec, AG	CALLISTO eye
2023-11-20	K232555	Topcon Healthcare Solutions	Harmony
2023-08-28	K231676	Carl Zeiss Meditec, AG	CALLISTO eye
2023-07-31	K232088	Altris, Inc.	Altris IMS
2022-10-31	K220929	Merit Cro, Inc.	Excelsior
2022-08-15	K213527	Carl Zeiss Meditec, AG	FORUM
2022-04-28	K211715	Retinai Medical AG	RetinAI Discovery
2021-09-13	K210396	Topcon Healthcare Solutions EMEA Oy	Harmony Referral System
2021-06-15	K203244	Konan Medical, Inc.	CellChek 20 rc
2020-12-24	K200422	Visionquest Biomedical, Inc.	Image Quality Analyzer (IQA)
2020-09-25	K201273	Canon, Inc.	ImageSPECTRUM
2020-08-03	K200954	Topcon Healthcare Solutions, Inc.	Glaucoma Module
2020-03-16	K200385	Integrated Ophthalmic Systems, Inc.	CONTINUUM PACS
2020-03-03	K200275	Ophthalmic Labs, Inc.	OVision Imaging System