FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
IGAR System (1001.A)
K Number: K223484
·
Decision Jul 20, 2023
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
1
Review Days
244
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Basic Information
- Device Name
- IGAR System (1001.A)
- K Number
- K223484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Insight Medbotics, Inc.
- Date Received
- November 18, 2022
- Decision Date
- July 20, 2023
- 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 |
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