510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K903030Substantially Equivalent

Sophycamera Dsm 315

Provino, Denmark, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903030 is the FDA 510(k) clearance record for SOPHYCAMERA DSM 315, a class I device, cleared for Provino on under FDA product code IYX (Camera, Scintillation (Gamma)). FDA records list one 510(k) clearance for Provino. As of , FDA records show no recalls naming K903030.

Clearance record

Decision date
Received
(111 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Provino Jellingvej5, Denmark, DK
Third party review
No

Clearances, product code IYX

Trailing 12 months

FDA records hold no clearances under product code IYX in the trailing twelve months.

FDA records show no clearances under product code IYX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IYX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260