510(k) K251286
- Device
- Affirm 400
- Applicant
- Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
- 510(k) number
- K251286
- Product code
- QFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-21
- Date received
- 2025-04-25
- Regulation
- 882.4950
- Classification name
- Diagnostic Neurosurgical Microscope Filter
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lu Ju
- Address
- 125 Cremona Dr. Suite 110 Goleta CA US 93117 93117
FDA Registration Numbers#
- 9615010
- 1000204638
- 3015967359
- 3043527620
- 3007456622
- 3003974370
Source Documents#
Other 510(k) Records For Product Code QFX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254030 | cCeLL405 | VPIX Medical, Inc. | 2026-10-02 |
| K240215 | BLUE 400; BLUE 400 S | Carl Zeiss Meditec, AG | 2024-06-28 |
| K232567 | Myriad SPECTRA Light Source | Nico Corporation | 2024-03-14 |
| K211346 | BLUE 400 | Carl Zeiss Meditec, AG | 2022-07-22 |
| DEN180024 | Leica FL400 | Leica Microsystems (Schweiz) AG | 2019-03-28 |