FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIVA ZSP2105CMI with QUBYX PerfectLum bundle
K Number: K160328
·
Decision Feb 25, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
2
Review Days
20
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Basic Information
- Device Name
- DIVA ZSP2105CMI with QUBYX PerfectLum bundle
- K Number
- K160328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Linden Group Corp
- Date Received
- February 5, 2016
- Decision Date
- February 25, 2016
- Product Code
- PGY
- 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 |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
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Other Clearances by The Linden Group Corp
| K Number | Device Name | ||
|---|---|---|---|
| K191705 | OptikView GUP2103CMI | Mar 16, 2020 | Substantially Equivalent |