Product Code: LWI
FDA class 2
21 CFR 892.1560
Ultrasound, Sinus
Radiology
The Sinus Ultrasound device (product code LWI) is a diagnostic radiology instrument that uses ultrasound technology to evaluate the paranasal sinuses, assisting in the diagnosis of sinusitis and other sinus conditions. Regulated under 21 CFR 892.1560 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the Radiology specialty with review by the Ear, Nose, Throat (EN) panel. It is not an implant and is not life-sustaining.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
9
Basic Information
- Product Code
- LWI
- Device Class
- FDA class 2
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K960421 | SINUSCAN 102/SINUSPRINT | Apr 16, 1997 | Substantially Equivalent | Ferguson Medical |
| K960044 | ULTRAMAX/MODEL NUMBER A1 | Aug 02, 1996 | Substantially Equivalent | Entlab OY |
| K960241 | CPR GENERAL SURGERY TRAY | Mar 22, 1996 | Substantially Equivalent | Custom Pack Reliability |
| K874081 | ENTERSCAN | Dec 31, 1987 | Substantially Equivalent | Pie Data Medical BV |