510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K912073Substantially Equivalent

Polaroid Helios Laser Imager

Polaroid Medical Corp., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912073 is the FDA 510(k) clearance record for POLAROID HELIOS LASER IMAGER, a class II device, cleared for Polaroid Medical Corp. on under FDA product code LMC (Camera, Multi Format, Radiological). FDA records list one 510(k) clearance for Polaroid Medical Corp. As of , FDA records show no recalls naming K912073.

Clearance record

Decision date
Received
(110 days to decision)
Product code
LMC Camera, Multi Format, Radiological
Regulation
21 CFR 892.2040
Device class
Class II
Review panel
Radiology
Applicant
Polaroid Medical Corp. C/O Hogan & Hartson, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code LMC

Trailing 12 months

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

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