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PowerLook AMP with Density Assessment GE OUS

FDA UDI

Class II (US FDA UDI)

by Icad, Inc.

Identity

Trade Name
PowerLook AMP with Density Assessment GE OUS FDA UDI
Generic Name
Basic diagnostic x-ray system application software FDA UDI
Model / Reference
DSC012-03 FDA UDI

Identifiers

Primary DI / UDI-DI
00850008977190 FDA UDI
510(k) Number
K180125 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Basic diagnostic x-ray system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Basic diagnostic x-ray system application software

PowerLook AMP with Density Assessment GE OUS by Icad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic diagnostic x-ray system application software.

Cleared under the same submission

K180125 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icad, Inc.

Sources (1)

  • FDA UDI 9d4de457-be1f-4876-9dbb-3736a7c4eeb5 33 fields · synced Jun 8, 2026