FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lung Image Analysis
K Number: K212494
·
Decision Sep 2, 2021
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
4
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Lung Image Analysis
- K Number
- K212494
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulmonx Corporation
- Date Received
- August 9, 2021
- Decision Date
- September 2, 2021
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.
Respiratory Gating for Scanners (2.1)
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE (TSX-308A/TSX-306A) V2.0
FDA 510(k)
FDA Class 2
·Radiology
Spectral CT Verida Family
FDA 510(k)
FDA Class 2
·Radiology
True Definition DL
FDA 510(k)
FDA Class 2
·Radiology
CT Rembra RT; CT Areta RT; CT Rembra
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM X.cite; SOMATOM X.ceed
FDA 510(k)
FDA Class 2
·Radiology