510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K921516Substantially Equivalent

P2900 X-Ray Generator

Precise Optics Photo Medic Equipment, Inc., Bay Shore NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921516 is the FDA 510(k) clearance record for P2900 X-RAY GENERATOR, a class I device, cleared for Precise Optics Photo Medic Equipment, Inc. on under FDA product code IZO (Generator, High-Voltage, X-Ray, Diagnostic). FDA records list 2 510(k) clearances for Precise Optics Photo Medic Equipment, Inc., from to . As of , FDA records show no recalls naming K921516.

Clearance record

Decision date
Received
(58 days to decision)
Product code
IZO Generator, High-Voltage, X-Ray, Diagnostic
Regulation
21 CFR 892.1700
Device class
Class I
Review panel
Radiology
Applicant
Precise Optics Photo Medic Equipment, Inc. 239 S. Fehr Way, Bay Shore NY
510(k) summary
Statement
Third party review
No

Clearances, product code IZO

Trailing 12 months

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

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