Data / Medical devices / United States / Subtle Medical Inc

Subtle Medical Inc: FDA-registered device maker in Menlo Park, CA, United States, 11 510(k) clearances

Name: Subtle Medical Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Subtle Medical Inc is registered with the FDA (registration 3015425142) in Menlo Park, CA, United States. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated May 15, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3015425142
Address: 883 Santa Cruz Avenue Suite 205, Menlo Park, CA, United States, 94025
Owner or operator: Subtle Medical Inc (10060008)
Roles: Manufacturer
First device listed: March 20, 2019
Registered through: 2027
Brand names listed: AiMIFY, SubtleALIGN, SubtleHD, SubtleHD(CT), SubtleHD(MR), SubtleHD(PET), SubtleHD-CT, SubtleHD-MR and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 15, 2026	K254120	SubtleHD-CT (1.x)	QIH	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
May 14, 2026	K254013	SubtleHD-PET (1.x)	LLZ	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
February 12, 2025	K243250	SubtleHD (1.x)	QIH	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
August 21, 2024	K240290	AiMIFY (1.x)	LLZ	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
July 11, 2024	K241329	SubtleSYNTH (1.x)	QIH	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
April 29, 2024	K233699	SubtleREFORMAT (1.x)	LLZ	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
May 11, 2023	K223623	SubtleMR (2.3.x)	LLZ	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
September 28, 2021	K211964	SubtlePET	KPS	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
February 26, 2021	K203182	SubtleMR	LLZ	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
September 16, 2019	K191688	SubtleMR	LLZ	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov
November 30, 2018	K182336	SubtlePET	KPS	Substantially Equivalent	Subtle Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.