PRENUVO Inc.

FDA Device Registration & Listing · Redwood City, CA, US · Registration 3017297314

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
3017297314
FEI Number
3017297314
Entity Name
PRENUVO Inc.
City/State/Country
Redwood City, CA, US
Establishment Address
2727 El Camino Real, Redwood City, CA 94061, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Prenuvo (Owner Number: 10092617)
Owner / Operator Contact Address
2727 El Camino Real, Redwood City, CA 94061, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242825
PMA Number
N/A

All Registered Proprietary Names

PRENUVO BODY COMPOSITION

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-01-29
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-01-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Prenuvo
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033504 General Electric Co. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 2003-11-25
K013636 GE Medical Systems SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 2002-01-24
K250443 Siemens Healthcare GmbH MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile 2025-06-16
K151015 Hitachi Medical Systems America, Inc. ECHELON Oval V 5.0 MRI System 2015-07-29
K910715 Philips Medical Systems (Cleveland), Inc. VISTA HPQ SYSTEM 1991-06-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014 Philips Medical Systems (Cleveland) Inc 2
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024 Philips North America Llc 2
Achieva 1.5T
Z-0390-2024 Philips North America Llc 2
Achieva 1.5T Conversion
Z-0391-2024 Philips North America Llc 2
Achieva 1.5T Initial System

Similar Registrations

Registration Number Establishment Name Location
3019844073 TracInnovations A/S Ballerup Hovedstaden, DK
3012169560 SIARON MEDICAL LTD Vancouver British Columbia, CA
3033536331 NEOSCAN SOLUTIONS GMBH Magdeburg Saxony-Anhalt, DE
3020162557 SPINTECH, INC. Bingham Farms, MI, US
3012354318 JIANGSU MAGSPIN INSTRUMENT CO., LTD Kunshan Jiangsu, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017297314. Last updated year: 2026. Please use registration number 3017297314 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.