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FDA-cleared K252856

PeekMed web

Peek Health, S.A.

Authorized purpose: PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and machine-learning-assisted knee segmentation and landmarking subject to clinician review and approval.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy for preoperative planning, including knee and labeled orthopedic regions
Decision
2025-12-22
FDA-cleared K252452

PeekMed web

Peek Health, S.A.

Authorized purpose: PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and machine-learning-assisted knee segmentation and landmarking subject to clinician review and approval.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy for preoperative planning, including knee and labeled orthopedic regions
Decision
2025-11-12
FDA-cleared K251096

PeekMed web

Peek Health, S.A.

Authorized purpose: PeekMed is a cloud web system for preoperative orthopedic planning from imported X-ray, CT, and MR images, with two-dimensional and three-dimensional visualization, measurements, and prosthetic templates for adults with injury or disability.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Hip; knee; upper limb; foot; and other labeled orthopedic anatomy
Decision
2025-07-14
FDA-cleared K250042

PeekMed web

Peek Health, S.A.

Authorized purpose: PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and procedure planning; qualified professionals must revise and approve the output using clinical assessment.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific surgical anatomy represented in imported medical imaging
Decision
2025-03-19
FDA-cleared K240926

PeekMed web

Peek Health, S.A.

Authorized purpose: PeekMed web is designed to help healthcare professionals perform preoperative planning for surgical procedures using imported patient imaging studies. The FDA material describes two-dimensional and three-dimensional image representation, measurements, templates, and a database of digital representations of surgical materials supplied by manufacturers.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy for surgical planning
Decision
2024-12-06