Chrysalis Intelligence · Product Codes · IZQ

IZQ · Unclassified

9 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
9
2020-07-02 → 2026-08-03
Last 12 months
4
Unique sponsors
3
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
Ulrich GmbH & Co. KG 6 2 2025-11-18
Imaxeon Pty, Ltd. 2 1 2025-09-24
ACIST Medical Systems, Inc. 1 1 2026-08-03
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
A4643 HCPCS High Automatic contrast injector supply code for radiographic procedures
36299 CPT Medium Unlisted vascular injection procedure; contrast injector is accessory to imaging procedures
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-03 K262115 ACIST Medical Systems, Inc. VueJect® Ultrasound Enhancing Agent Delivery System
2025-11-18 K252281 Ulrich GmbH & Co. KG ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
2025-11-07 K251295 Ulrich GmbH & Co. KG ulrichINJECT CT Motion (XD 8000)
2025-09-24 K252689 Imaxeon Pty, Ltd. MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
2024-11-05 K241849 Imaxeon Pty, Ltd. MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
2024-08-26 K241850 Ulrich GmbH & Co. KG ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
2024-04-19 K233737 Ulrich GmbH & Co. KG ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
2021-08-06 K210541 Ulrich GmbH & Co. KG ulrichINJECT CT motion
2020-07-02 K192872 Ulrich GmbH & Co. KG ulrichINJECT CT Motion