Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1626313

FEI Number

1626313

Entity Name

DIGISONICS, INC.

City/State/Country

Raleigh, NC, US

Establishment Address

305 Church at N Hills St, 6th Floor, Raleigh, NC 27609, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Intelerad Medical Systems Incorporated (Owner Number: 9040757)

Owner / Operator Contact Address

800, boul. de Maisonneuve Est, 14th floor, MONTREAL, CA-QC H2L 4L8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Doctors Review System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2000-03-20

Official Correspondent

Eric Llewelyn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Intelerad Medical Systems Incorporated

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9615916	INTELERAD MEDICAL SYSTEMS INCORPORATED	MONTREAL Quebec, CA
3008012314	LUMEDX	Raleigh, NC, US
3022435840	Intelerad USA	Raleigh, NC, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1626313. Last updated year: 2026. Please use registration number 1626313 when referencing this establishment in official correspondence.