IZL · System, X-Ray, Mobile · Chrysalis Intelligence

Device class

Class II

Regulation 892.1720

Total clearances

2020-04-13 → 2026-08-03

Last 12 months

Unique sponsors

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.1720

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
DRGEM Corporation	4	1	2026-05-14
Sedecal., Sa.	4	0	2023-08-21
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)	4	0	2021-01-06
Oxos Medical, Inc.	3	0	2022-02-04
Samsung Electronics Co., Ltd.	3	0	2024-10-01
Poskom Co., Ltd.	3	2	2026-02-23
Carestream Health	3	1	2026-03-11
First Source, Inc.	2	0	2024-07-03
Minxray, Inc.	2	0	2021-03-19
Shenzhen Browiner Tech Co., Ltd.	2	0	2024-12-09
Solutions For Tomorrow AB	2	1	2025-10-24
Neuf, Inc.	2	0	2023-08-16
VATECH Co., Ltd.	2	0	2022-02-11
Shanghai United Imaging Healthcare Co., Ltd.	2	0	2024-10-10
Livermoretech, Inc.	2	0	2025-05-28
Micro-X Limited	2	0	2021-05-21
Remedi Co., Ltd.	2	0	2025-07-31
Suzhou Powersite Electric Co., Ltd.	1	0	2022-11-01
Bontech Co., Ltd.	1	1	2025-09-12
Siemens Medical Solutions	1	0	2023-07-25
H&abyz Co., Ltd.	1	0	2025-08-04
Shantou Institute of Ultrasonic Instruments Co., Ltd.	1	1	2026-06-18
Ecoray Co., Ltd.	1	0	2025-04-18
Hdt Co., Ltd.	1	0	2022-07-10
Vmi Tecnologias Ltda	1	0	2020-06-19

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
71046	CPT	—	Medium	Chest X-ray, portable; mobile X-ray systems typically used for portable imaging
77999	CPT	—	Medium	Unlisted fluoroscopic procedure; mobile systems used in various clinical settings

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-03	K260236	GEMSS HEALTHCARE CO., LTD.	XLITE
2026-06-18	K253058	Shantou Institute of Ultrasonic Instruments Co., Ltd.	Portable DR Imaging System
2026-05-14	K260085	DRGEM Corporation	RAYMO Mobile X-ray System (Model: RAYMO)
2026-03-11	K253185	Carestream Health	Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
2026-02-23	K253244	Poskom Co., Ltd.	AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
2025-12-19	K250976	Poskom Co., Ltd.	Airbile-100
2025-10-24	K251710	Solutions For Tomorrow AB	Mobile X-ray unit (!M1)
2025-09-12	K243864	Bontech Co., Ltd.	BONX805
2025-08-22	K251443	DRGEM Corporation	PROMO
2025-08-04	K251223	H&abyz Co., Ltd.	HnX-P1, HnX-PB
2025-07-31	K250597	Remedi, Inc.	REMEX Xcam6
2025-07-29	K243473	Prognosys Medical Systems Private Limited	PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS
2025-07-18	K250750	Dk Medical Systems Co., Ltd.	INNOVISION-P5
2025-05-28	K244049	Livermoretech, Inc.	Europa (Alternative: AiRTouch) portable X-ray system
2025-05-06	K241980	Solutions For Tomorrow AB	!M1
2025-04-18	K241996	Ecoray Co., Ltd.	ULTRA 1040
2024-12-16	K242015	DRGEM Corporation	TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
2024-12-10	K241505	Carestream Health, Inc.	DRX-Revolution Mobile X-ray System
2024-12-09	K240841	Shenzhen Browiner Tech Co., Ltd.	Digital Radiography System (ManntiX B, ManntiX K)
2024-10-10	K242515	Shanghai United Imaging Healthcare Co., Ltd.	uDR 380i Pro
2024-10-01	K242651	Samsung Electronics Co., Ltd.	GM85
2024-09-20	K234108	Energy Resources International Co., Ltd.	ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
2024-07-03	K240009	First Source, Inc.	iQFlex Pro
2024-03-28	K240284	Shenzhen Browiner Tech Co., Ltd.	Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)
2024-02-14	K233678	Philips Medical Systems Dmc GmbH	Radiography 7000 M