Cleared Special

iSR`obot Mona Lisa 2.0 (K232320) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232320 · Biobot Surgical Pte., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
140d
Days
Class 2
Risk

K232320 is an FDA 510(k) clearance for the iSR`obot Mona Lisa 2.0. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Biobot Surgical Pte., Ltd. (Singapore, SG). The FDA issued a Cleared decision on December 21, 2023 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biobot Surgical Pte., Ltd. devices

Submission Details

510(k) Number K232320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2023
Decision Date December 21, 2023
Days to Decision 140 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 212
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K232320.
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
K233401 · Eieling Technology Limited · Feb 2024
Bladder Scanner
K230986 · Avantsonic Technology Co., Ltd. · Dec 2023
Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
K231889 · Ultrasound Biotechnology (Shanghai) Co., Ltd. · Dec 2023
K3900 Ultrasound Imaging System
K230511 · Maui Imaging · Oct 2023
Velacur
K232459 · Sonic Incytes · Sep 2023
SiteRite™ 9 Ultrasound System
K231283 · Bard Access Systems, Inc. (C.R. Bard, Inc.) · Sep 2023