Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029900829

FEI Number

3029900829

Entity Name

SMART SOFT HEALTHCARE

City/State/Country

Varna, BG

Establishment Address

113 Gen. Kolev Str., suite 7.2, Varna 9002, BG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Smart Soft Healthcare (Owner Number: 10088940)

Owner / Operator Contact Address

113 Gen. Kolev Str., suite 7.2, Varna, BG-03 9002, BG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241211

PMA Number

N/A

All Registered Proprietary Names

CoLumbo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-07-16

Official Correspondent

Stefka Stefanova

US Agent Details

Nedelcho Georgiev Email: nedelcho.georgiev@columbo.me Phone: (302) 8035507

Related Public Records

Same Entity

Smart Soft Healthcare

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
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30

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3042852277	REMEDY LOGIC	New York, NY, US
3027986210	MRIGUIDANCE B.V.	Utrecht, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029900829. Last updated year: 2026. Please use registration number 3029900829 when referencing this establishment in official correspondence.