FDA 510(k) Premarket Notification K101768: MIE SCINTRON GAMMA CAMERA SYSTEMS

Submission Details & Decision

Normalized public record details for 510(k) notification K101768.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K101768

Applicant / Sponsor

Miegmbh

Device Name

MIE SCINTRON GAMMA CAMERA SYSTEMS

Product Code

KPS

Decision Date

2010-10-05

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2010-06-23

Related Establishments / Registrations

SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1034973 View Registration
SYNTERMED, INC. Registration: 1066019 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1423253 View Registration
MIE AMERICA, INC. Registration: 1423348 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
MEDIMAGE, INC. Registration: 1833124 View Registration
Digirad Diagnostic Imaging, LLC Registration: 2031050 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2126677 View Registration
CANON MEDICAL INFORMATICS, INC. Registration: 2134213 View Registration
Anholt Technologies Inc. Registration: 2247992 View Registration
RBM SERVICES, LLC. Registration: 2320968 View Registration
E-Z-EM, INC. Registration: 2411512 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Philips Medical Systems Nederland B.V. Registration: 3000976525 View Registration
Siemens Healthineers AG Registration: 3002808157 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC Registration: 3004504920 View Registration
SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. Registration: 3004754211 View Registration
INVIA, LLC Registration: 3004993756 View Registration
MIE GMBH Registration: 3005128583 View Registration
BAY SHORE MEDICAL EQUIPMENT, LLC Registration: 3005810333 View Registration
METROPOLIS INTERNATIONAL, LLC Registration: 3005877899 View Registration
CMR NAVISCAN CORPORATION Registration: 3005945241 View Registration
Spectrum Dynamics Medical Ltd. Registration: 3006209933 View Registration
INTER MEDICAL MEDIZINTECHNIK GMBH Registration: 3006611212 View Registration
GEXPRO, a Division of REXEL USA, Inc. Registration: 3007545404 View Registration
NEUSOFT POSITRON MEDICAL SYSTEMS CO.,LTD. Registration: 3007675950 View Registration
Spectrum Dynamics Medical Inc. Registration: 3008007310 View Registration
HM PRODUCT SOLUTIONS, LTD. Registration: 3008355361 View Registration
EvERX PTY LTD Registration: 3008496839 View Registration
LJ BUSINESS CORPORATION Registration: 3008632256 View Registration
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. Registration: 3008962177 View Registration
CEDARS SINAI MEDICAL CENTER Registration: 3009136051 View Registration
LBN MEDICAL A/S Registration: 3009196578 View Registration
Philips Healthcare (Suzhou) Co., Ltd. Registration: 3009529630 View Registration
KUEHNE GMBH Registration: 3009963139 View Registration
Probo Medical Ltd Registration: 3010398867 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. Registration: 3011015597 View Registration
Medical Resale PTY Limited Registration: 3011416394 View Registration
United Imaging Healthcare North America, Inc Registration: 3011950073 View Registration
ADVANCED IMAGING SERVICES, INC. Registration: 3012085143 View Registration
SIRTEX MEDICAL INC. Registration: 3012690638 View Registration
Repair Operations Center Registration: 3013679558 View Registration
FLEXRAY MEDICAL Registration: 3014134519 View Registration
EVERX JAPAN CO. LTD Registration: 3014343100 View Registration
COMBINOSTICS Registration: 3014470527 View Registration
UIH TECHNOLOGIES, LLC Registration: 3014809646 View Registration
CONVERGENT IMAGING SOLUTIONS Registration: 3014954414 View Registration
ELEKTA SOLUTIONS AB Registration: 3015232217 View Registration
CAN TECHNOMED TRADING LTD. Registration: 3015276088 View Registration
Subtle Medical Inc Registration: 3015425142 View Registration
Philips Medical Systems Technologies Ltd. Registration: 3015763655 View Registration
Philips Medical Systems Nederland B.V. Registration: 3015777306 View Registration
MULTIFUNCTIONAL IMAGING LLC Registration: 3016007746 View Registration
Scandinavian Medical Solutions A/S Registration: 3017375271 View Registration
ULTRASPECT USA, LLC Registration: 3018788582 View Registration
EverFortune.AI Co., Ltd. Registration: 3021032044 View Registration
MEDICAL IMAGING SALE AND SERVICE INC Registration: 3021059265 View Registration
RADIALIS INC. Registration: 3022742930 View Registration
BLOCK IMAGING SAS Registration: 3023003446 View Registration
20MED PTE LTD Registration: 3026047529 View Registration
MEDICAPS CO., LTD. Registration: 3026391023 View Registration
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 3027338963 View Registration
MEDIVEST GROUP Registration: 3027339477 View Registration
BENELUX IMAGING Registration: 3029521953 View Registration
X3D APS Registration: 3030186509 View Registration
DIGIT SYSTEMS SPA Registration: 3030210400 View Registration
IONIC HEALTH TECHNOLOGIES SA Registration: 3030982377 View Registration
BLOCK IMAGING PARTS & SERVICE Registration: 3031503890 View Registration
POSITRIGO AG Registration: 3032577207 View Registration
GE Medical Systems Israel, Functional Imaging Registration: 3033524251 View Registration
BRIGHTONIX IMAGING INC. Registration: 3034246184 View Registration
PROBO MEDICAL SAS Registration: 3035950510 View Registration
FUJITA CO., LTD. Registration: 3036666444 View Registration
CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Registration: 8030233 View Registration
GE MEDICAL SYSTEMS SCS Registration: 9611343 View Registration
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 9613299 View Registration
GE HANGWEI MEDICAL SYSTEMS CO., LTD. Registration: 9613445 View Registration
WIPRO GE HEALTHCARE PRIVATE LTD Registration: 9613936 View Registration
CANON INC. Registration: 9614698 View Registration
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. Registration: 9617978 View Registration
HERMES MEDICAL SOLUTIONS, AB Registration: 9710645 View Registration

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