FDA-cleared K182130
iSchemaView RAPID
iSchemaView, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-12-27
Vendor
iSchemaView, Inc.
15 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K200760
Rapid ASPECTS
iSchemaView Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2020-06-26
FDA-cleared K200941
Rapid LVO
iSchemaView Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2020-07-09
FDA-cleared K220499
Rapid PE Triage and Notification (PETN)
iSchemaView Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-05-17
FDA-cleared K221248
Rapid LVO
iSchemaView Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2022-05-31
FDA-cleared K221456
Rapid ICH
iSchemaView Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2022-09-12
FDA-cleared K222884
Rapid NCCT Stroke
iSchemaView, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-03-02
FDA-cleared K230074
Rapid Aneurysm Triage and Notification
iSchemaView Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-07-27
FDA-cleared K232436
Rapid SDH
iSchemaView, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-10-25
FDA-cleared K233512
Rapid (6.0)
iSchemaView, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-01-16
FDA-cleared K232156
Rapid ASPECTS (v3)
iSchemaView, Inc.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-01-19
FDA-cleared K243350
Rapid Neuro3D
iSchemaView, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-22
FDA-cleared K243378
Rapid MLS
iSchemaview Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-28
FDA-cleared K251533
Rapid Obstructive Hydrocephalus, Rapid OH
iSchemaView Inc.
Image analysis/processing for Head/Neck using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Head/Neck
- Decision
- 2025-09-04
FDA-cleared K251987
Rapid Aortic Measurements
iSchemaView, Inc.
Image analysis/processing for Cardiovascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Cardiovascular
- Decision
- 2025-09-23