Chrysalis Intelligence · Product Codes · IZF

IZF · System, X-Ray, Tomographic

Radiology · 8 clearances · 5 unique sponsors

Device class
Class II
Regulation 892.1740
Total clearances
8
2020-03-09 → 2026-02-02
Last 12 months
2
Unique sponsors
5
Medical specialty
Radiology
Review panel
RA
Regulation number
892.1740
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Nano-X Imaging , Ltd. 4 1 2026-02-02
General Medical Merate S.P.A 1 0 2021-10-26
Pausch Medical GmbH 1 0 2023-01-26
Agfa N.V. 1 0 2020-03-09
Adaptix Limited 1 1 2025-11-06
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
71260 CPT Medium CT chest; tomographic X-ray systems are CT equipment billing via procedure codes
76377 CPT Medium 3D rendering with interpretation; tomographic imaging procedure
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-02-02 K252649 Nano-X Imaging , Ltd. TAP2D
2025-11-06 K252133 Adaptix Limited Adaptix Ortho350
2025-04-16 K250850 Nano-X Imaging , Ltd. Nanox.ARC X
2024-12-04 K242395 Nano-X Imaging , Ltd. Nanox.ARC
2023-04-28 K222934 Nano-X Imaging , Ltd. Nanox.ARC
2023-01-26 K221949 Pausch Medical GmbH Ortho Device, ADAPTIX 3D Orthopedic Imaging System
2021-10-26 K213081 General Medical Merate S.P.A CLISIS SYSTEMS, Discovery RF180
2020-03-09 K193262 Agfa N.V. DR 600 with Tomosynthesis