FDA-cleared K170172

UNiD Spine Analyzer

MEDICREA INTERNATIONAL

UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries.

Modality
MRI
Anatomy
Spine
Decision
2017-05-24
FDA-cleared K180091

UNiD Spine Analyzer

Medicrea International

Image analysis/processing for Spine using MRI.

Modality
MRI
Anatomy
Spine
Decision
2018-02-08
FDA-cleared K183204

Bone VCAR (BVCAR)

GE Medical Systems SCS

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2019-04-08
FDA-cleared K202404

BoneMRI

MRIguidance B.V

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2021-12-22
FDA-cleared K212005

UNiD Spine Analyzer

MEDICREA International, Inc.

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2022-01-12
FDA-cleared K212365

BoneView

Gleamer

Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2022-03-01
FDA-cleared K221632

Spine CAMP™

Medical Metrics, Inc.

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2022-10-18
FDA-cleared K221762

BoneMRI v1.4

MRlguidance B.V.

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2022-11-16
FDA-cleared K230197

BoneMRI v1.6

MRIguidance B.V.

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2023-02-22
FDA-cleared K222176

BoneView

Gleamer

Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2023-03-02
FDA-cleared K223514

Spectral Bone Marrow

GE Medical Systems, LLC

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2023-03-09
FDA-cleared K231668

Spine CAMP™ (1.1)

Medical Metrics, Inc.

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2023-07-07
FDA-cleared K223424

Spine Auto Views

GE Medical Systems SCS

Image analysis/processing for Spine using CT/CTA.

Modality
CT/CTA
Anatomy
Spine
Decision
2023-07-13
FDA-cleared K232023

Momentum Spine

Momentum Health Inc.

Image analysis/processing for Spine using Radiotherapy planning imaging.

Modality
Radiotherapy planning imaging
Anatomy
Spine
Decision
2023-10-04
FDA-cleared K223757

Bonelogic

Disior Ltd

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2023-12-08
FDA-cleared K233030

BoneMRI

MRIguidance B.V

Image analysis/processing for Bone using CT/CTA.

Modality
CT/CTA
Anatomy
Bone
Decision
2024-03-01
FDA-cleared K240582

VEA Align; spineEOS

EOS imaging

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2024-06-25
FDA-cleared K251629

UNiD™ Spine Analyzer

Medicrea International S.A.S. (Medtronic)

Image analysis/processing for Spine using Radiological images; modality varies or is not specified in FDA list.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine
Decision
2025-08-07
FDA-cleared K251747

VEA Align; spineEOS

EOS imaging

Image analysis/processing for Spine using X-ray/Radiography.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2025-08-15