PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED

FDA Device Registration & Listing · Bengaluru Karnataka, IN · Registration 3016250464

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016250464
FEI Number
3016250464
Entity Name
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
City/State/Country
Bengaluru Karnataka, IN
Establishment Address
#168/1, Machohalli, Dasanapura Hobli, Next to Vani Vidyalaya, Off Magadi Road, Bengaluru Karnataka 560091, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Prognosys Medical Systems (Owner Number: 10062153)
Owner / Operator Contact Address
#168/1, Machohalli, Dasanapura Hobli, Next to Vani Vidyalaya, Off Magadi Road, Bengaluru, IN-KA 560091, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

PRORAD X-Ray Flat Panel Detector with DROC Prorad Atlas Ultraportable Plus Prorad Atlas Ultraportable

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2025-12-29
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2025-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

Karyl Haskell Business: Yellowstone Consultants LLC Email: karylh@yellowstoneconsultants.com Phone: (952) 2215343

Related Public Records

Same Entity

Prognosys Medical Systems
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25
K153059 Minxray, Inc. HF1202H PowerPlus Portable X-ray Equipment 2016-02-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-1470-2023 FUJIFILM Healthcare Americas Corporation 2
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024 FUJIFILM Healthcare Americas Corporation 2
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

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9614698 CANON INC. OTAWARA-SHI Tochigi, JP
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016250464. Last updated year: 2026. Please use registration number 3016250464 when referencing this establishment in official correspondence.
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