Discovery SL

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: Discovery SL FDA UDI
Generic Name: Bone absorptiometric x-ray system, dual-energy FDA UDI
Device Name: The Discovery series bone densitometers are computer-assisted X-Ray scanners used to aid a physician in measuring bone mineral density (BMD) and determining fracture risk. All Discovery Series densitometers allow comparison of estimated BMD from a subject's proximal femur (hip), lumbar spine, and forearm to reference data for sex and ethnicity matched controls. Discovery Wi, W, and A models can also be used for estimating the lean body mass and fat mass of non-osseous tissues. Discovery C, W, SL, and A models can be used for performing a visual or quantitative assessment of vertebral bodies for diagnosis of vertebral deformity. Discovery SL and A models are capable of measuring the lateral vertebral BMD in the supine lateral position. FDA UDI
Model / Reference: Discovery SL FDA UDI
Description: The Discovery series bone densitometers are computer-assisted X-Ray scanners used to aid a physician in measuring bone mineral density (BMD) and determining fracture risk. All Discovery Series densitometers allow comparison of estimated BMD from a subject's proximal femur (hip), lumbar spine, and forearm to reference data for sex and ethnicity matched controls. Discovery Wi, W, and A models can also be used for estimating the lean body mass and fat mass of non-osseous tissues. Discovery C, W, SL, and A models can be used for performing a visual or quantitative assessment of vertebral bodies for diagnosis of vertebral deformity. Discovery SL and A models are capable of measuring the lateral vertebral BMD in the supine lateral position. FDA UDI

Identifiers

Catalog Number: Discovery-SL FDA UDI
Primary DI / UDI-DI: 15420045506893 FDA UDI
510(k) Number: K023398 FDA UDI
FDA Product Code: KGI FDA UDI
GMDN Term: Bone absorptiometric x-ray system, dual-energy FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1170 FDA UDI
Commercial Distribution: Not 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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Discovery SL by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K023398 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 II	Pending data

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

Manufacturer

Manufacturer: Hologic, Inc.

Sources (1)

FDA UDI 8ce4daf7-3352-48a8-a16b-aaa4271780ec 38 fields · synced May 31, 2026