FDA 510(k) Premarket Notification K243523: NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

Submission Details & Decision

Normalized public record details for 510(k) notification K243523.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K243523

Applicant / Sponsor

Siemens Medical Solutions USA, Inc.

Device Name

NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

Product Code

JAK

Decision Date

2025-02-12

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-11-14

Related Establishments / Registrations

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ACIST MEDICAL SYSTEMS, INC. Registration: 2134243 View Registration
INTRICON CORPORATION Registration: 2134850 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
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FUJIFILM CORPORATION Registration: 3001722928 View Registration
J. MORITA MFG. CORP. Registration: 3002807636 View Registration
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Sterigenics US LLC Registration: 3002907620 View Registration
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HORIZONS INTL. CORP. Registration: 3004083736 View Registration
Sony Corporation Registration: 3004091527 View Registration
Xoran Technologies, LLC Registration: 3004198450 View Registration
Bracco Injeneering S.A. Registration: 3004753774 View Registration
EDDA TECHNOLOGY, INC. Registration: 3004857110 View Registration
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INVIA, LLC Registration: 3004993756 View Registration
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CEFLA S.C. Registration: 3006610845 View Registration
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VIDA DIAGNOSTICS Registration: 3007233544 View Registration
GEXPRO, a Division of REXEL USA, Inc. Registration: 3007545404 View Registration
AGITO MEDICAL Registration: 3007562060 View Registration
PULMONX, Corp. Registration: 3007797756 View Registration
Spectrum Dynamics Medical Inc. Registration: 3008007310 View Registration
MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration
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EvERX PTY LTD Registration: 3008496839 View Registration
LJ BUSINESS CORPORATION Registration: 3008632256 View Registration
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