510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842895Substantially Equivalent

Wba - I.r.i.s.

Siemens Gammasonics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842895 is the FDA 510(k) clearance record for WBA - I.R.I.S., a class I device, cleared for Siemens Gammasonics, Inc. on under FDA product code JAM (Scanner, Whole Body, Nuclear). FDA records list 53 510(k) clearances for Siemens Gammasonics, Inc., from to . As of , FDA records show no recalls naming K842895.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JAM Scanner, Whole Body, Nuclear
Regulation
21 CFR 892.1330
Device class
Class I
Review panel
Radiology
Applicant
Siemens Gammasonics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JAM

Trailing 12 months

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

FDA records show no clearances under product code JAM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JAM, 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