Biopsy Digit

FDA UDI

Class II (US FDA UDI)

by I.m.s. Internazionale Medico Scientifica Srl

Identity

Trade Name: BIOPSY DIGIT FDA UDI
Generic Name: Mammographic stereotactic biopsy system FDA UDI
Device Name: Biopsy Digit SL is a medical device intended to be used for mamnmographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. FDA UDI
Model / Reference: BIOPSY DIGIT SL FDA UDI
Description: Biopsy Digit SL is a medical device intended to be used for mamnmographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. FDA UDI

Identifiers

Catalog Number: 9201-01 FDA UDI
Primary DI / UDI-DI: 08033837190202 FDA UDI
510(k) Number: K113607 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

Yes

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

Dimensions & Sizes

Size: Height — 330 Millimeter FDA UDI
Depth — 303 Millimeter FDA UDI
Width — 358 Millimeter FDA UDI

Category: Mammographic stereotactic biopsy system

Biopsy Digit by I.m.s. Internazionale Medico Scientifica Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mammographic stereotactic biopsy system.

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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
ENCOR® — SENORX, INC. · Class II

Cleared under the same submission

K113607 also covers:

BIOPSY DIGIT — IMS GIOTTO SPA

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: I.m.s. Internazionale Medico Scientifica Srl

Sources (1)

FDA UDI e9635ffd-715d-42e1-9c68-76681ef43fb2 37 fields · synced May 30, 2026