Samsung HME America, Inc.

FDA Device Registration & Listing · Danvers, MA, US · Registration 3004938766

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004938766
FEI Number
3004938766
Entity Name
Samsung HME America, Inc.
City/State/Country
Danvers, MA, US
Establishment Address
14 Electronics Ave, Danvers, MA 01923, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Samsung Electronics Co., Ltd. (Owner Number: 10043488)
Owner / Operator Contact Address
129, Samsung-ro, Yeongtong-gu, Suwon-si, KR-41 16677, KR
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K170238
PMA Number
N/A

All Registered Proprietary Names

OmniTom Elite BodyTom 64 OmniTom Elite with PCD BodyTom Elite VetTom 32

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-07-11
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-05-20
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-09-09
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2017-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Samsung Electronics Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3032116890 SAMSUNG ELECTRONICS CO., LTD. Seoul, KR
3017616353 Samsung Electronics Co., Ltd. Mobile eXperience Business Suwon-si Gyeonggi, KR
3010300212 Samsung Electronics Co., Ltd. Suwon-si Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K123106 Samsung Electronics Co., Ltd. DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A 2013-06-20
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12
K781431 General Electric Co. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 1978-09-07
K231574 FUJIFILM Healthcare Americas Corporation Scenaria View 4.2 2023-10-12
K233583 FUJIFILM Healthcare Americas Corporation FCT iSTREAM Phase 1 2024-04-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017 Philips Medical Systems 2
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004938766. Last updated year: 2026. Please use registration number 3004938766 when referencing this establishment in official correspondence.
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