FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
InstaRISPACS / InstaZFP / InstaMobi v5.0
K Number: K182572
·
Decision Apr 12, 2019
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
1
Review Days
206
Basic Information
- Device Name
- InstaRISPACS / InstaZFP / InstaMobi v5.0
- K Number
- K182572
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meddiff Technologies Pvt. Ltd.
- Date Received
- September 18, 2018
- Decision Date
- April 12, 2019
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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