Smart Finder

FDA UDI

Class II (US FDA UDI)

by Ims Giotto Spa

Identity

Trade Name: SMART FINDER FDA UDI
Generic Name: Mammographic stereotactic biopsy system FDA UDI
Device Name: The SMART FINDER is intended to be used for mammographic procedures requiring stereotactic guidance,such as fine needle aspiration, needle biopsy and guide wire placement. FDA UDI
Model / Reference: 28000-02 FDA UDI
Description: The SMART FINDER is intended to be used for mammographic procedures requiring stereotactic guidance,such as fine needle aspiration, needle biopsy and guide wire placement. FDA UDI

Identifiers

Primary DI / UDI-DI: 08056977360113 FDA UDI
510(k) Number: K203509 FDA UDI
FDA Product Code: IZH FDA UDI
GMDN Term: Mammographic stereotactic biopsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mammographic stereotactic biopsy system

Smart Finder by Ims Giotto Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mammographic stereotactic biopsy system.

ATEC SAPPHIRE 100 — Hologic, Inc. · Class II
Brevera Breast Biopsy System — Hologic, Inc. · Class II
BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
Brevera Breast Biopsy System — Hologic, Inc. · Class II
Eviva — Hologic, Inc. · Class I
ENCOR® — SENORX, INC. · Class II
Mammotome — Devicor Medical Products, Inc. · Class II
Affirm Breast Biopsy Guidance System — Hologic, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ims Giotto Spa

Sources (1)

FDA UDI b8019d08-cacb-499f-b451-d945c210f1a3 34 fields · synced Jun 8, 2026