510(k) K243881

Device: HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
Applicant: Bracco Diagnostics, Inc.
510(k) number: K243881
Product code: KPS
Decision: Substantially Equivalent (SESE)
Decision date: 2025-03-03
Date received: 2024-12-18
Regulation: 892.1200
Classification name: System, Tomography, Computed, Emission
Medical specialty: Radiology
Review panel: Radiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Elyssa Murray
Address: 510 Carnegie Center Princeton NJ US 08540 08540

FDA Registration Numbers

3030982377
3005810333
3014954414
3036666444
3014343100
8022257
8030233
3015777306
1423253
3011416394
3014134519
3007545404
3021059265
1034973
3009196578
3002808157
1833124
3007675950
3016007746
9611343
3012085143
3008007310
3010398867
3033524251
3008355361
3013679558
3000976525
3009963139
3010703925
3015276088
3035950510
2134213
3014809646
9614698
3015425142
2031050
3030210400
2126677
3027339477
3005877899
9617978
3029521953
3015763655
9710645
3018788582
3008632256
3011950073
3011015597
3026391023
3008496839
3017375271
3003477135
1424263
2411512
3009136051
3015232217
3032577207
3023003446
3005945241
3005128583
3027338963
3000126629
3006209933
9613936
3026047529
9613299
3022742930
3021032044
2320968
1450662
3031503890
3006611212
3004993756
3004754211
1423348
1066019
9613445
3034246184
2247992

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code KPS

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K260524	uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)	Shanghai United Imaging Healthcare Co., Ltd.	2026-04-03
K253564	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)	Shanghai United Imaging Healthcare Co., Ltd.	2026-02-13
K254001	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)	Spectrum Dynamics Medical, Ltd.	2026-01-13
K253844	AnyScan 3.0 NM Scanner Family	Mediso Medical Imaging Systems, Ltd.	2025-12-30
K251370	Cartesion Prime (PCD-1000A/3) V10.21	Canon Medical Systems Corporation	2025-12-01
K251401	PennPET Explorer Positron Emission Tomograph	Trustees of the University of Pennsylvania	2025-11-25
K252477	Hybrid Viewer (00859873006240)	Hermes Medical Solutions AB	2025-09-09
K250170	PHAROS	Brightonix Imaging	2025-08-15
K251561	Biograph Trinion	Siemens Medical Solutions USA, Inc.	2025-07-31
K251839	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)	Shanghai United Imaging Healthcare Co., Ltd.	2025-07-17
K251671	Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems	Siemens Medical Solutions USA, Inc.	2025-07-03
K251153	Aurora	Ge Medical Systems Israel	2025-06-12
K241266	Imaging system of positron emission and X-ray computed tomography (DigitMI 930)	Raysolution Healthcare Co., Ltd.	2025-01-27
K243605	Aurora	Ge Medical Systems Israel, Functional Imaging	2025-01-17