Invenia

FDA UDI

Class III (US FDA UDI)

by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Identity

Trade Name: Invenia FDA UDI
Generic Name: Breast ultrasound imaging system FDA UDI
Model / Reference: ABUS Review Software FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682100090 FDA UDI
PMA Number: P110006 FDA UDI
FDA Product Code: PAA FDA UDI
GMDN Term: Breast ultrasound imaging system FDA UDI

Classification

Device Class: Class III 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Breast ultrasound imaging system

Invenia by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breast ultrasound imaging system.

Invenia — GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC · Class III
SonoCine Image Acquisition Station — Sonocine, Inc. · Class II
SoftVue — Delphinus Medical Technologies · Class III
ACUSON S2000 Automated Breast Volume Scanner — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
Breast Volume Navigator (BVN) — Metritrack, Inc. · Class II
SOFIA — IVU IMAGING CORPORATION · Class II
Invenia — GE Medical Systems Ultrasound & Primary Care Diagnostics LLC · Class III
Invenia — GE Medical Systems Ultrasound & Primary Care Diagnostics LLC · Class III

Cleared under the same submission

P110006 also covers:

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 III	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Sources (1)

FDA UDI a587860a-f6a4-4d27-9efe-bbab7ee3d182 33 fields · synced Jun 4, 2026