Cleared Traditional

K240771 - PRORAD X-Ray Flat Panel Detector with DROC

K240771 is an FDA 510(k) clearance for PRORAD X-Ray Flat Panel Detector with DROC, manufactured by Prognosys Medical Systems Private Limited. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K240771 · Prognosys Medical Systems Private Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
236d
Days
Class 2
Risk

K240771 is an FDA 510(k) clearance for the PRORAD X-Ray Flat Panel Detector with DROC. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Prognosys Medical Systems Private Limited (Bangalore, IN). The FDA issued a Cleared decision on November 12, 2024 after a review of 236 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Prognosys Medical Systems Private Limited devices

FDA 510(k) Submission Details - K240771

510(k) Number K240771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2024
Decision Date November 12, 2024
Days to Decision 236 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 107d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 259
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K240771.
Yushan X-Ray Flat Panel Detector
K243171 · Innocare Optoelectronics Corp. · Dec 2024
SKR 3000
K241319 · Konica Minolta, Inc. · Nov 2024
VIVIX-S 1751S
K241125 · Vieworks Co., Ltd. · Nov 2024
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
K241346 · Aspen Imaging Healthcare, Inc. · Nov 2024
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
K242394 · Rayence Co., Ltd. · Sep 2024
0909FCC, 0909FCC-HS
K240371 · Rayence Co., Ltd. · Mar 2024