JAZZ IMAGING

FDA Device Registration & Listing · San Jose, CA, US · Registration 3013503781

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
3013503781
FEI Number
3013503781
Entity Name
JAZZ IMAGING
City/State/Country
San Jose, CA, US
Establishment Address
1710 Zanker Rd, San Jose, CA 95112, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Jazz Imaging (Owner Number: 10054578)
Owner / Operator Contact Address
1710 Zanker Rd, San Jose, CA 95112, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241495
PMA Number
N/A

All Registered Proprietary Names

SOLO Classic

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2017-04-04
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-12-27

Official Correspondent

Todd Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Jazz Imaging
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
K221008 Shanghai Handy Medical Equipment Co., Ltd. HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) 2022-06-22
K160788 Ray Co., Ltd. RIOScan (RPS500) 2016-04-15
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number Establishment Name Location
3042046320 QPIX SOLUTIONS, INC. Morrisville, NC, US
3020117925 ATHLOS OY Espoo Uusimaa, FI
2032641 CYBER MEDICAL IMAGING, INC. Los Angeles, CA, US
3004706313 VATECH CO., LTD. Hwaseong-si Gyeonggi, KR
3010281549 J. MORITA MFG. CORP., TOTTORI FACTORY Kurayoshi Tottori, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013503781. Last updated year: 2026. Please use registration number 3013503781 when referencing this establishment in official correspondence.
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