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Model 4 CT Calibration Phantom

FDA UDI

Class II (US FDA UDI)

by Mindways Software, Inc.

Identity

Trade Name
Model 4 CT Calibration Phantom FDA UDI
Generic Name
Bone densitometry x-ray phantom, test object FDA UDI
Device Name
Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software. FDA UDI
Model / Reference
4 FDA UDI
Description
Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software. FDA UDI

Identifiers

Primary DI / UDI-DI
B052PHCTM40 FDA UDI
510(k) Number
K002113 FDA UDI
K030330 FDA UDI
K140342 FDA UDI
K894854 FDA UDI
FDA Product Code
KGI FDA UDI
GMDN Term
Bone densitometry x-ray phantom, test object FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1170 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

Yes

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: Bone densitometry x-ray phantom, test object

Model 4 CT Calibration Phantom by Mindways Software, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone densitometry x-ray phantom, test object.

Cleared under the same submission

K002113 also covers:

K030330 also covers:

K140342 also covers:

K894854 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mindways Software, Inc.

Sources (1)

  • FDA UDI a19b2f0d-df0b-4831-a2a2-f2fa65aa0741 35 fields · synced Jun 9, 2026