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Prognosys Medical Systems Private Limited: FDA-registered device maker in Bengaluru Karnataka, India, 3 510(k) clearances

Name: Prognosys Medical Systems Private Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Prognosys Medical Systems Private Limited is registered with the FDA (registration 3016250464) in Bengaluru Karnataka, India. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 29, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3016250464
Address: #168/1, Machohalli, Dasanapura Hobli Next to Vani Vidyalaya, Off Magadi Road, Bengaluru Karnataka, India, 560091
Owner or operator: Prognosys Medical Systems (10062153)
Roles: Manufacturer
First device listed: December 23, 2019
Registered through: 2026
Brand names listed: PRORAD X-Ray Flat Panel Detector with DROC, ProRad 2FC, ProRad 3NC, Prorad Atlas Ultraportable, Prorad Atlas Ultraportable Plus

Devices it lists

Device	Product code	Class	Role	Source
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 29, 2025	K243473	PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS	IZL	Substantially Equivalent	Prognosys Medical Systems Private Limited	accessdata.fda.gov
November 12, 2024	K240771	PRORAD X-Ray Flat Panel Detector with DROC	MQB	Substantially Equivalent	Prognosys Medical Systems Private Limited	accessdata.fda.gov
January 24, 2019	K183541	ProRad 2FC and ProRad 3NC Stationary Radiographic Systems	KPR	Substantially Equivalent	Prognosys Medical Systems Private Limited	accessdata.fda.gov

Compare with other makers

Updated July 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.