MICRODOSE SI
FDA 510(k) clearance K123995 · decided 2013-02-01
Clearance details
- K-number
- K123995
- Device name
- MICRODOSE SI
- Applicant
- Philips Digital Mammography Sweden AB
- Decision
- Substantially Equivalent
- Date received
- 2012-12-26
- Decision date
- 2013-02-01
- Days to decision
- 37 days
- Clearance type
- Special
- Product code
- MUE
- Device class
- 2
- Regulation number
- 892.1715
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Solna, SE
- Third-party review
- No
- Expedited review
- No
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| VIVIX-M (K241113) | Vieworks Co., Ltd. | 2025-01-16 |
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| RMF-2000 (K220073) | DRTECH Corporation | 2023-01-26 |
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| Aspire Cristalle (K212873) | Fujifilm Corporation | 2022-05-27 |
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| Helianthus (K202822) | Metaltronica Spa | 2021-12-15 |
Recalls involving this device
No recalls on record reference this clearance.