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SpineCAMP

FDA UDI

Class II (US FDA UDI)

by Medical Metrics, Inc.

Identity

Trade Name
SpineCAMP FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
Spine CAMP™ is a fully-automated image processing software device. It is designed to be used with X-ray images and is intended to aid medical professionals in the measurement and assessment of spinal parameters. Spine CAMP™ is capable of calculating distances, angles, linear displacements, angular displacements, and mathematical combinations of these metrics to characterize the morphology, alignment, and motion of the spine. These analysis results are presented in the form of reports, annotated images, and visualizations of intervertebral motion to support their interpretation. FDA UDI
Model / Reference
SpineCAMP FDA UDI
Description
Spine CAMP™ is a fully-automated image processing software device. It is designed to be used with X-ray images and is intended to aid medical professionals in the measurement and assessment of spinal parameters. Spine CAMP™ is capable of calculating distances, angles, linear displacements, angular displacements, and mathematical combinations of these metrics to characterize the morphology, alignment, and motion of the spine. These analysis results are presented in the form of reports, annotated images, and visualizations of intervertebral motion to support their interpretation. FDA UDI

Identifiers

Primary DI / UDI-DI
00860011655701 FDA UDI
510(k) Number
K231668 FDA UDI
FDA Product Code
QIH FDA UDI
GMDN Term
Radiology DICOM image processing 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

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology DICOM image processing application software

SpineCAMP by Medical Metrics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Metrics, Inc.

Sources (1)

  • FDA UDI 713d8ea0-5f92-4d4f-b4d4-b1e8c42f8678 35 fields · synced May 30, 2026