KPS · System, Tomography, Computed, Emission

Device class

Class II

Regulation 892.1200

Total clearances

2020-01-26 → 2026-07-28

Last 12 months

Unique sponsors

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.1200

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
Shanghai United Imaging Healthcare Co., Ltd.	15	3	2026-07-28
Siemens Medical Solutions USA, Inc.	13	1	2026-05-21
Canon Medical Systems Corporation	4	1	2025-12-01
GE Healthcare	4	0	2023-04-27
Hermes Medical Solutions AB	4	1	2025-09-09
GE Medical Systems SCS	3	0	2022-11-22
Spectrum Dynamics Medical, Ltd.	2	1	2026-01-13
Philips Medical Systems Nederland B.V.	2	0	2021-08-06
Mcgovern Medical School	2	0	2023-08-21
Ge Medical Systems Israel, Functional Imaging	2	0	2025-01-17
Siemens Healthineers	1	0	2024-07-26
Raysolution Healthcare Co., Ltd.	1	0	2025-01-27
Cardiovascular Imaging Technologies	1	0	2020-08-11
Shimadzu Corporation Medical Systems Division	1	0	2024-05-24
Ge Medical Systems, LLC	1	0	2021-08-20
Miegmbh	1	0	2020-08-27
Positrigo AG	1	0	2024-07-15
Syntermed	1	0	2023-03-30
Sirtex Medical US Holdings, Inc.	1	0	2020-10-23
Ever Fortune.Ai, Co., Ltd.	1	0	2022-05-31
Bracco Diagnostics, Inc.	1	0	2025-03-03
Combinostics OY	1	0	2023-09-14
Siemens Medical Solution USA, Inc.	1	0	2020-02-12
Subtle Medical, Inc.	1	0	2021-09-28
Brightonix Imaging	1	0	2025-08-15

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
78801	CPT	—	High	PET scan; brain
78802	CPT	—	High	PET scan; chest
78803	CPT	—	High	PET scan; abdomen and pelvis

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-28	K261427	Shanghai United Imaging Healthcare Co., Ltd.	uMI Panvivo (uMI Panvivo M)
2026-05-21	K261315	Siemens Medical Solutions USA, Inc.	Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family
2026-04-03	K260524	Shanghai United Imaging Healthcare Co., Ltd.	uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
2026-02-13	K253564	Shanghai United Imaging Healthcare Co., Ltd.	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
2026-01-13	K254001	Spectrum Dynamics Medical, Ltd.	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
2025-12-30	K253844	Mediso Medical Imaging Systems, Ltd.	AnyScan 3.0 NM Scanner Family
2025-12-01	K251370	Canon Medical Systems Corporation	Cartesion Prime (PCD-1000A/3) V10.21
2025-11-25	K251401	Trustees of the University of Pennsylvania	PennPET Explorer Positron Emission Tomograph
2025-09-09	K252477	Hermes Medical Solutions AB	Hybrid Viewer (00859873006240)
2025-08-15	K250170	Brightonix Imaging	PHAROS
2025-07-31	K251561	Siemens Medical Solutions USA, Inc.	Biograph Trinion
2025-07-17	K251839	Shanghai United Imaging Healthcare Co., Ltd.	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
2025-07-03	K251671	Siemens Medical Solutions USA, Inc.	Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
2025-06-12	K251153	Ge Medical Systems Israel	Aurora
2025-03-03	K243881	Bracco Diagnostics, Inc.	HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
2025-01-27	K241266	Raysolution Healthcare Co., Ltd.	Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
2025-01-17	K243605	Ge Medical Systems Israel, Functional Imaging	Aurora
2024-12-12	K243538	Shanghai United Imaging Healthcare Co., Ltd.	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
2024-11-08	K241364	Hermes Medical Solutions AB	Hybrid Viewer (00859873006189)
2024-10-30	K243186	Siemens Medical Solutions USA, Inc.	Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family
2024-08-30	K241585	Shanghai United Imaging Healthcare Co., Ltd.	uMI Panorama
2024-08-15	K241596	Shanghai United Imaging Healthcare Co., Ltd.	uMI Panvivo
2024-08-08	K241665	Ge Medical Systems Israel, Functional Imaging	Omni Legend
2024-07-26	K241898	Siemens Healthineers	Symbia SPECT and SPECT/CT Systems
2024-07-15	K241751	Positrigo AG	NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat