KPR · System, X-Ray, Stationary · Chrysalis Intelligence

Device class

Class II

Regulation 892.1680

Total clearances

2020-01-02 → 2026-06-15

Last 12 months

Unique sponsors

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.1680

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
Siemens Medical Solutions USA, Inc.	6	0	2022-05-17
Carestream Health, Inc.	5	1	2026-01-20
DRGEM Corporation	4	0	2025-01-07
Shanghai United Imaging Healthcare Co., Ltd.	3	2	2025-11-26
Philips Medical Systems Dmc GmbH	3	0	2024-06-13
Konica Minolta Healthcare Americas, Inc.	3	0	2022-07-27
Siemens Medical Solutions	3	0	2025-07-31
Ge Hualun Medical Systems Co. , Ltd.	3	1	2025-08-28
Jpi Healthcare Co, Ltd.	2	1	2026-06-15
DRTECH Corporation	2	0	2024-10-23
Shimadzu Corporation	2	0	2024-03-28
Dk Medical Systems Co., Ltd.	2	1	2026-04-10
Radmedix, LLC	2	0	2023-10-25
Eos Imaging	2	0	2024-08-06
Sedecal., Sa.	2	0	2021-02-01
Skanray Technologies Limited	2	0	2023-10-27
Shenzhen Sontu Medical Imaging Equipment Co., Ltd.	1	0	2025-01-06
Philips Healthcare (Suzhou) Co., Lit.	1	0	2020-07-10
Nanoray Biotech Co., Ltd.	1	0	2022-04-29
Allengers Medical Systems Limited	1	0	2022-10-26
Samsung Electronics Co., Ltd.	1	0	2024-09-19
Adani	1	0	2020-05-26
Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.	1	0	2020-01-28
Dk Medical System	1	0	2025-01-03
Vmi Tecnologias Ltda	1	0	2020-12-01

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; 2 views
71047	CPT	—	Medium	Chest X-ray; 3 views

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-15	K260482	Jpi Healthcare Co, Ltd.	DRE Duo
2026-04-10	K253446	Dk Medical Systems Co., Ltd.	AeroDR TX c02
2026-01-20	K250954	Carestream Health	DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
2025-11-26	K252000	Shanghai United Imaging Healthcare Co., Ltd.	uDR Arria & uDR Aris
2025-09-19	K251167	Shanghai United Imaging Healthcare Co., Ltd.	uDR Aurora CX
2025-08-28	K250788	Ge Hualun Medical Systems Co. , Ltd.	Definium Tempo Select
2025-08-01	K250790	Dk Medical Systems Co., Ltd.	INNOVISION-DXII
2025-07-31	K250738	Siemens Medical Solutions	YSIO X.pree
2025-01-07	K242019	DRGEM Corporation	GXR-Series Diagnostic X-Ray System
2025-01-06	K242499	Shenzhen Sontu Medical Imaging Equipment Co., Ltd.	Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
2025-01-03	K242119	Dk Medical System	INNOVISION-EXII
2024-11-01	K241068	Shanghai United Imaging Healthcare Co., Ltd.	uDR 780i
2024-10-23	K242847	DRTECH Corporation	EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);
2024-10-01	K242678	Ge Hualun Medical Systems Co. , Ltd.	Definium Pace Select ET
2024-09-19	K242478	Samsung Electronics Co., Ltd.	GF85 (models GF85-3P, GF85-SP)
2024-08-06	K233920	Eos Imaging	EOSedge
2024-07-26	K233530	DRTECH Corporation	EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)
2024-06-13	K233662	Philips Medical Systems Dmc GmbH	Radiography 7300 C
2024-05-21	K233543	Siemens Medical Solutions	YSIO X.pree
2024-03-28	K233719	Shimadzu Corporation	FDR Visionary Suite
2024-03-12	K233381	Carestream Health, Inc.	DRX-Evolution Plus System
2024-02-23	K233722	Shimadzu Corporation	RADspeed Pro
2023-11-29	K233532	Siemens Medical Solutions	MULTIX Impact E
2023-11-02	K230800	GEMSS HEALTHCARE CO., LTD.	XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
2023-10-27	K231761	Skanray Technologies Limited	PodSKAN HF Diagnostic X-ray System