Radiology · 510(k) · 2026
SubtleHD-PET (1.x)
Subtle Medical, Inc.. Cleared by FDA on 14 May 2026 under submission K254013, product code LLZ (system, image processing, radiological). What FDA's record says, in FDA's words.
Device record · K254013
- Device. SubtleHD-PET (1.x)DEVICE
- Company. Subtle Medical, Inc.COMPANY
- Decision. 14 May 2026, 510(k), substantially equivalent (traditional review); received 15 December 2025DECISION
- Panel. RadiologyPANEL
- Product code. LLZ, System, Image Processing, RadiologicalCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (16 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K254013Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? ISubtleHD-PET (1.x) Please provide your Indications for Use below. SubtleHD-PET is an image processing software intended for noise reduction of PET images (including PET/ CT and PET/MR) obtained with any kind of radiotracer (e.g. 18F-FDG). I Please select the types of uses (select one or both, as ZPrescription Use (21 CFR 801 Subpart D) S]Over-The-Counter Use (21 CFR 801 Subpart C)applicable). SubtleHD-PET 510(k) Summary Table 1. Contact Details and Date Summary Prepared: 13 April 2026 Contact Details: Company Name: Subtle Medical, Inc. Company Address: 883 Santa Cruz Ave, Suite 205 Menlo Park, CA 94025 United States Applicant Name: Mr Ajit Shankaranarayanan Application Telephone: 650-448-4285 Applicant Email: [email protected] : Device Trade Name SubtleHD-PET (1.x) Common Name: Medical image management and processing system
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, MRI
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 19,970 reports filed against devices carrying product code LLZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · IntelliSpace Cardiovascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101631
Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that the ISCV could only be accessed in Web-Only mode on the workstation. The device was in clinical use at the time of the event, and no adverse events or harm were reported in the complaint ((b)(4)).Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · IntelliSpace Cardiovascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101632
Philips received a complaint on the IntelliSearch Cardiovascular (ISCV) indicating that customer reported that study retrieval from the archive was either failing or taking an excessively long time to complete. The device was in clinical use at the time of the event, and no adverse events or harm were reported in the complaint (b)(4).Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · IntelliSpace CardioVascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101634
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that DICOM import crashed occasionally as there was a PDFClinicalContentExecuter error.. The device was in clinical use at the time of event.Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on […]
30 September 2026 · Malfunction · IntelliSpace CardioVascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101635
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user could not save the findings. The device was in clinical use at the time of event. Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on clinical decision-making if it were to recur, it is determined that this […]
30 September 2026 · Malfunction · IntelliSpace Cardiovascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101636
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported that it was not possible to view previous studies in Echo Module. The device was in clinical use at the time of event. Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on clinical decision-making if it […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code LLZ, in Radiology, from Subtle Medical, Inc., or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
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