FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICAD VERALOOK CTC CAD SOFTWARE
K Number: K091529
·
Decision Aug 4, 2010
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
14
Review Days
439
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
- ICAD VERALOOK CTC CAD SOFTWARE
- K Number
- K091529
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icad, Inc.
- Date Received
- May 22, 2009
- Decision Date
- August 4, 2010
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
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
Other Clearances by Icad, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240417 | ProFound Detection (V4.0) | Nov 8, 2024 | Substantially Equivalent |
| K211506 | PowerLook Density Assessment V4.0 | Jul 12, 2021 | Substantially Equivalent |
| K203822 | ProFound AI Software V3.0 | Mar 12, 2021 | Substantially Equivalent |
| K191994 | ProFound AI Software V2.1 | Oct 4, 2019 | Substantially Equivalent |
| K182373 | PowerLook Tomo Detection V2 Software | Dec 6, 2018 | Substantially Equivalent |
| K180125 | PowerLook Density Assessment Software | Apr 5, 2018 | Substantially Equivalent |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Feb 25, 2016 | Substantially Equivalent |
| K141343 | AXXENT CERVICAL APPLICATOR | Sep 5, 2014 | Substantially Equivalent |
| K123442 | XOFT AXXENT CERVICAL APPLICATORS | Feb 27, 2013 | Substantially Equivalent |
| K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | Jan 17, 2013 | Substantially Equivalent |