FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANSCOPE XT SYSTEM
K Number: K073677
·
Decision Aug 1, 2008
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
14
Applicant Total
5
Review Days
217
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
- SCANSCOPE XT SYSTEM
- K Number
- K073677
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aperio Technologies
- Date Received
- December 28, 2007
- Decision Date
- August 1, 2008
- Product Code
- NQN
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQN), ordered by most recent decision date.
GENASIS HIPATH IHC FAMILY
FDA 510(k)
FDA Class 2
·Hematology
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
FDA 510(k)
FDA Class 2
·Hematology
VIRTUOSO SYSTEM FOR IHC ER (SPI)
FDA 510(k)
FDA Class 2
·Hematology
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
FDA 510(k)
FDA Class 2
·Hematology
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
FDA 510(k)
FDA Class 2
·Hematology
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
FDA 510(k)
FDA Class 2
·Hematology