FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
S-SCAN, MODEL 9800020010
K Number: K100670
·
Decision Apr 5, 2010
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
67
Review Days
27
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
- S-SCAN, MODEL 9800020010
- K Number
- K100670
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Esaote, S.p.A.
- Date Received
- March 9, 2010
- Decision Date
- April 5, 2010
- Product Code
- MOS
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOS), ordered by most recent decision date.
0.55T 12Ch Breast Coil
FDA 510(k)
FDA Class 2
·Radiology
HD 8Ch Wrist Array
FDA 510(k)
FDA Class 2
·Radiology
GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only
FDA 510(k)
FDA Class 2
·Radiology
Smart Fit TorsoCardiac 1.5T
FDA 510(k)
FDA Class 2
·Radiology
GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only
FDA 510(k)
FDA Class 2
·Radiology
3.0T AIR 32CH HNA
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Esaote, S.p.A.
| K Number | Device Name | ||
|---|---|---|---|
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Apr 6, 2026 | Substantially Equivalent |
| K260746 | S-scan Open (100001800) | Mar 27, 2026 | Substantially Equivalent |
| K251901 | Magnifico Open (100009900) | Mar 5, 2026 | Substantially Equivalent |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Nov 25, 2025 | Substantially Equivalent |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Jun 18, 2025 | Substantially Equivalent |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | May 16, 2025 | Substantially Equivalent |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910) | Jun 26, 2024 | Substantially Equivalent |
| K230179 | 6440 MyLabX90 | Nov 29, 2023 | Substantially Equivalent |
| K212419 | Magnifico Open, Magnifico MSK | Feb 4, 2022 | Substantially Equivalent |
| K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | Sep 16, 2021 | Substantially Equivalent |