Chrysalis Intelligence · Product Codes · IZI

IZI · Unclassified

12 clearances · 10 unique sponsors

Device class
Regulation —
Total clearances
12
2020-01-17 → 2026-05-28
Last 12 months
3
Unique sponsors
10
Medical specialty
Review panel
Regulation number
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
Surgvision GmbH 3 0 2024-03-20
Aesculap, Inc. 1 0 2021-01-21
Novadaq Technologies Ulc (A Part of Stryker) 1 0 2023-06-05
Diagnostic Green GmbH 1 1 2025-09-22
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) 1 0 2025-06-27
Onlume, Inc. 1 0 2020-01-17
Synaptive Medical, Inc. 1 0 2024-03-25
Carl Zeiss Meditec, Inc. 1 0 2023-06-20
Surgimage Corporation 1 1 2026-05-13
Stryker Endoscopy 1 1 2026-05-28
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.

CodeTypeDescriptionConfidenceRationale
75625 CPT High Aortography; angiographic X-ray systems bill under vascular/cardiac imaging procedure codes
93563 CPT Medium Cardiac angiography; angiographic X-ray system procedure code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-28 K261037 Stryker Endoscopy 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
2026-05-13 K253181 Surgimage Corporation SURGIMAGE SIM 1000H Fluorescence Imaging Platform
2025-09-22 K243645 Diagnostic Green GmbH IC-Flow™ Imaging System 2.0
2025-06-27 K243077 Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) Affirm 800
2024-03-25 K231986 Synaptive Medical, Inc. Modus IR
2024-03-20 K234090 Surgvision GmbH EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
2023-06-20 K231075 Carl Zeiss Meditec, Inc. Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
2023-06-05 K230727 Novadaq Technologies Ulc (A Part of Stryker) SPY Portable Handheld Imaging (SPY-PHI) System
2023-02-28 K222240 Surgvision GmbH EXPLORER AIR® II
2022-02-25 K214097 Surgvision GmbH Explorer Air II
2021-01-21 K202391 Aesculap, Inc. DIR 800
2020-01-17 K192761 Onlume, Inc. Asimov-MKS Imaging System