System, Tomography, Computed, Emission

Product Code: KPS

Radiology Diagnostic Nuclear Medicine Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1200

• Radiation Type: Ionizing
• Radition Safety: None
• Annual Reports: No

Products Classified as KPS

5370

System, Tomography, Computed, Emission

Emission Computed Tomography System.

Total Product Life Cycle (TPLC) Devices

5370

System, Tomography, Computed, Emission

Emission Computed Tomography System.

FDA Consensus Standards

• System, Tomography, Computed, Emission [33222]: 21 CFR §892.1200 🔎

Pre-market Notifications for KPS

K221932	Omni Legend	GE Healthcare
K214062	Radialis PET Camera	Radialis Inc.
K212604	Symbia VA10A Family	Siemens Medical Solutions USA, Inc.
K212004	MyoSPECT, MyoSpect ES	GE Healthcare
K211846	Discovery MI Gen2	GE Medical Systems, LLC.
K211764	Vereos PET/CT	Philips Medical Systems Nederland B.V.
K211247	PET VCAR	GE Medical Systems SCS
K210880	Vereos PET/CT	Philips Medical Systems Nederland B.V.
K210557	Symbia VA10A Family	Siemens Medical Solutions USA, Inc.
K210450	BBX-PET Scanner	Prescient Imaging, LLC
K210418	HYPER Focus	Shanghai United Imaging Healthcare Co.,Ltd.
K210262	Biograph Vision Quadra PET/CT System	Siemens Medical Solutions USA, Inc.
K210173	StarGuide	GE Healthcare
K210001	HYPER AiR	Shanghai United Imaging Healthcare Co.,Ltd.
K203314	Cartesion Prime (PCD-1000A/3) V10.8	Canon Medical Systems Corporation

Global Unique Device Identification Database

• 00884838059559: System, tomography, computed, emission
• 00864687000247: System, Tomography, Computed, Emission
• 00864687000209: System, Tomography, Computed, Emission
• 00861333000309: System, Tomography, Computed, Emission
• 00859873006073: System, Tomography, Computed, Emission
• 00859873006059: System, Tomography, Computed, Emission
• 00859873006042: System, Tomography, Computed, Emission
• 00859873006004: System, Tomography, Computed, Emission
• 00850816007119: System, Tomography, Computed, Emission
• 00850816007102: System, Tomography, Computed, Emission
• 00850816007096: System, Tomography, Computed, Emission
• 00850816007089: System, Tomography, Computed, Emission
• 00850816007072: System, Tomography, Computed, Emission
• 00850816007065: System, Tomography, Computed, Emission
• 00850816007058: System, Tomography, Computed, Emission

Maude Adverse Events

SYMBIA INTEVO BOLD	SIEMENS MEDICAL SOLUTIONS USA, INC.	2020-03-19
SKYLIGHT IMAGING SYSTEM	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2020-02-07
BIOGRAPH VISION	SIEMENS MEDICAL SOLUTIONS USA, INC.	2020-01-31
DISCOVERY MI	GE MEDICAL SYSTEMS, LLC	2020-01-17
PRECEDENCE SPECT/CT IMAGING SYSTEM	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-12-17
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-12-16
NUCLEAR MEDICINE CAMERA	GE	2019-11-26
E.CAM	SIEMENS MEDICAL SOLUTIONS USA, INC.	2019-11-04
DISCOVERY PET CT	GE MEDICAL SYSTEMS, INC.	2019-10-15
HAWKEYE 4	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	2019-10-11
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-10-04
SIEMENS 128 EDGE DUAL ENERGY	SIEMENS MEDICAL SOLUTIONS USA, INC.	2019-09-30
BRIGHTVIEW X	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-09-27
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-09-27
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-09-26
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-09-10
SYMBIA EVO EXCEL	SIEMENS MEDICAL SOLUTIONS USA, INC.	2019-08-27
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-08-22
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-08-16
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-08-09
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-08-08
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-08-08
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-08-06
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-29
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-29
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-26
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-26
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-26
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-18
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-18
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-18
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-18
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-17
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-17
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-17
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-17
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-17
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-17
BRIGHTVIEW X	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-16
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-16
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-16
BRIGHTVIEW X	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-16
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-16
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-16
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-15
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-15
BRIGHTVIEW XCT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-12
BRIGHTVIEW SPECT	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.	2019-07-11
HAWKEYE 4	GE MEDICAL SYSTEMS ISRAEL	2019-07-02
SIGNATURE E.CAM DUAL CAMERA	SIEMENS MEDICAL SOLUTIONS USA, INC.	2019-07-01