Manufacturer registered with FDA

Jazz Imaging

San Jose, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10054578Manufacturer
Device types listed
1
Brands and models
2
510(k) clearances
12017–2017
Markets registered in
1United States
Establishments
1United States
2017: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Jazz Imaging currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Digital Extraoral Source X-Ray SystemMUH · Class 2Dental X-ray unitsMaker
MinorSolo
2017

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Jazz Imaging as the applicant.

Decided510(k)DeviceDevice type
9 Mar 2017K163224JAZZ SOLO SensorMUH Digital Extraoral Source X-Ray System

Also lists devices cleared under other names

Jazz Imaging lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Jazz Imaging, LLC Dba Jazz Imaging (1).

Decided510(k)DeviceApplicantDevice type
10 Dec 2021K213637JAZZ Solo sensorJazz Imaging, LLC Dba Jazz ImagingMUH Digital Extraoral Source X-Ray System

Registered establishments

EstablishmentLocationWhat it does
JAZZ IMAGINGFDA reg. 3013503781San Jose, CA, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10054578). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.