FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CT Sim Laser System
K Number: K152303
·
Decision Sep 11, 2015
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
27
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- CT Sim Laser System
- K Number
- K152303
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5780
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gammex, Inc.
- Date Received
- August 14, 2015
- Decision Date
- September 11, 2015
- Product Code
- IWE
- 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 |
|---|---|---|---|
| IWE | Monitor, Patient Position, Light-Beam | FDA class 1 | Radiology |
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