FDA 510(k)
FDA class 2
Unknown
🇩🇪 Germany
YELLOW 560 Fluorescence Module
K Number: K162991
·
Decision Jul 24, 2017
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
45
Review Days
270
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
- YELLOW 560 Fluorescence Module
- K Number
- K162991
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, AG
- Date Received
- October 27, 2016
- Decision Date
- July 24, 2017
- Product Code
- IZI
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZI), ordered by most recent decision date.
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k)
FDA Class 2
·Radiology
SURGIMAGE SIM 1000H Fluorescence Imaging Platform
FDA 510(k)
FDA Class 2
·Radiology
IC-Flow Imaging System 2.0
FDA 510(k)
FDA Class 2
·Radiology
Affirm 800
FDA 510(k)
FDA Class 2
·Radiology
Modus IR
FDA 510(k)
FDA Class 2
·Radiology
EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Carl Zeiss Meditec, AG
| K Number | Device Name | ||
|---|---|---|---|
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Jan 10, 2025 | Substantially Equivalent |
| K233911 | VISULAS combi | Sep 6, 2024 | Substantially Equivalent |
| K240215 | BLUE 400; BLUE 400 S | Jun 28, 2024 | Substantially Equivalent |
| K233421 | RESCAN 700 | Mar 8, 2024 | Substantially Equivalent |
| K232944 | CALLISTO eye | Dec 21, 2023 | Substantially Equivalent |
| K232159 | QEVO System | Sep 21, 2023 | Substantially Equivalent |
| K231676 | CALLISTO eye | Aug 28, 2023 | Substantially Equivalent |
| K230858 | QUATERA 700 | Jul 31, 2023 | Substantially Equivalent |
| K213527 | FORUM | Aug 15, 2022 | Substantially Equivalent |
| K211346 | BLUE 400 | Jul 22, 2022 | Substantially Equivalent |