FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Straight Arm DDR
K Number: K214012
·
Decision Jan 12, 2022
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
6
Review Days
21
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Basic Information
- Device Name
- Straight Arm DDR
- K Number
- K214012
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Konica Minolta Healthcare Americas, Inc.
- Date Received
- December 22, 2021
- Decision Date
- January 12, 2022
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Konica Minolta Healthcare Americas, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252996 | Universal 1417PI | Jun 12, 2026 | Substantially Equivalent |
| K221853 | OTC DDR | Jul 27, 2022 | Substantially Equivalent |
| K214030 | Universal DR 1748 | Jan 21, 2022 | Substantially Equivalent |
| K203743 | EXA | Dec 10, 2021 | Substantially Equivalent |
| K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography | Jan 15, 2020 | Substantially Equivalent |