Radiology · 510(k) · 2021
SubtlePET
Subtle Medical, Inc.. Cleared by FDA on 28 September 2021 under submission K211964, product code KPS (system, tomography, computed, emission). What FDA's record says, in FDA's words.
Device record · K211964
- Device. SubtlePETDEVICE
- Company. Subtle Medical, Inc.COMPANY
- Decision. 28 September 2021, 510(k), substantially equivalent (traditional review); received 24 June 2021DECISION
- Panel. RadiologyPANEL
- Product code. KPS, System, Tomography, Computed, EmissionCODE
- Regulation. 21 CFR 892.1200, Class IIREG
- Source. FDA database entry · decision document (7 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.
SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images. T able 2 compares the indications for use of the predicate and subject device. T able 2. Indications of Use Comparison.
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.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,054 reports filed against devices carrying product code KPS. 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:
24 September 2026 · Other · Omni Legend · report MW6002811
During PET/CT, camera shut down following the computed tomography portion of the scan, prior to the Positron emission tomography scan. Pallet release button didn't work when trying to remove the patient from the gantry ¿ patient remained stuck inside the machine. Once GE was contacted, the person on the phone could not assist with giving instructions to the technologists to release the table to slide the patient out. Our technologists asked if anyone could give them a call back to help, and […]
3 September 2026 · Other · Symbia Evo Excel Pro Specta X3 · report MW6001906
Seimen's service rep was onsite to perform our 6 month PM on our new Symbia Pro Specta X3 nuclear camera. Upon inspection of the equipment, the service rep found that the camera head was missing 3 of the 6 screws that bolt it to the stand. This camera rotates around the patients.
3 August 2026 · Other · PET/CT SCANNER · UNKNOWN · report MW6000320
I had gone to a scheduled appointment for an MRI exam, and what I learned soonafterwards was that I was put into a pet/ct scanner instead. I was actually lead tobelieve I was having an MRI, but they knew they were doing a ct scan. What they haddone to me before finishing up the scan is that they turned up the energy significantly toover radiate my liver. The high dose radiation had cause internal injuries resulting inradiation induced liver disease and massive congestion within the liver with […]
1 July 2026 · Injury · SYMBIA INTEVO BOLD · SIEMENS MEDICAL SOLUTIONS USA, INC. · report 1423253-2026-00001
A COLLIMATOR CHANGE SEQUENCE WAS INITIATED WHILE THE PATIENT REMAINED POSITIONED ON THE IMAGING BED WITH THE HEAD SECURED. SYSTEM RECORDS INDICATE THAT THE COMMAND TO INITIATE THE SEQUENCE WAS ENTERED AT THE OPERATOR CONSOLE. THIS IS CONTRARY TO PRODUCT LABELING INSTRUCTIONS. DURING THE SEQUENCE, THE PATIENT WAS ADVANCED INTO THE COLLIMATOR BY APPROXIMATELY 16 MM (APPROXIMATELY 5/8 INCH). TOUCHPAD INPUTS WERE NOT EFFECTIVE IN STOPPING MOTION, AS TOUCHPAD FUNCTIONALITY IS DISABLED DURING AN […]
19 February 2026 · Injury · 870 TANDEM · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · report 9613299-2026-00001
DURING SERVICING OF AN 870 TANDEM SYSTEM, WHILE ASSEMBLING THE REAR CT GANTRY COVER, THE FIELD ENGINEER SUSTAINED A LACERATION AFTER CONTACTING AN INNER PART OF THE COVER. THE RESULTING LACERATION ON THE LEFT MIDDLE FINGER REQUIRED SUTURES.
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 KPS, in Radiology, from Subtle Medical, Inc., or cleared in 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.