510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251286Substantially Equivalent

Affirm 400

Digital Surgery Systems, Inc. (D.B.A True Digital Surgery), Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251286 is the FDA 510(k) clearance record for Affirm 400, a class II device, cleared for Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) on under FDA product code QFX (Diagnostic Neurosurgical Microscope Filter). FDA's definition for product code QFX reads: "A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition". FDA records list 2 510(k) clearances for Digital Surgery Systems, Inc. (D.B.A True Digital Surgery), from to . As of , FDA records show no recalls naming K251286.

Clearance record

Decision date
Received
(271 days to decision)
Product code
QFX Diagnostic Neurosurgical Microscope Filter
Regulation
21 CFR 882.4950
Device class
Class II
Review panel
Neurology
Applicant
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) 125 Cremona Dr., Goleta CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFX

Trailing 12 months
1 clearance under product code QFX in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QFX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260