FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
21HQ513D
K Number: K212295
·
Decision Dec 3, 2021
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
27
Review Days
134
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Basic Information
- Device Name
- 21HQ513D
- K Number
- K212295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lg Electronics.Inc
- Date Received
- July 22, 2021
- Decision Date
- December 3, 2021
- Product Code
- PGY
- 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 |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
Similar 510(k) Clearances
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Other Clearances by Lg Electronics.Inc
| K Number | Device Name | ||
|---|---|---|---|
| K261213 | Medical Monitor (40HT513D) | Jun 12, 2026 | Substantially Equivalent |
| K251209 | Medical Monitor (32HS710S) | Jun 12, 2025 | Substantially Equivalent |
| K243439 | Medical Monitor (27HS714S) | Jan 28, 2025 | Substantially Equivalent |
| K241402 | Medical Monitor (32HR734S) | Aug 12, 2024 | Substantially Equivalent |
| K233599 | X-Clever (ASHK100G) | Mar 18, 2024 | Substantially Equivalent |
| K240130 | Medical Monitor (21HQ613D) | Feb 15, 2024 | Substantially Equivalent |
| K232985 | 24HR513C | Dec 11, 2023 | Substantially Equivalent |
| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Aug 15, 2023 | Substantially Equivalent |
| K230845 | 32HL512D, 31HN713D, 32HQ713D | Apr 27, 2023 | Substantially Equivalent |
| K223423 | 32HQ713D | Mar 1, 2023 | Substantially Equivalent |