Syngo.Ct Cardiac Function

Q: What is the product code of K110366?

The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.

FDA 510(k) K110366 · Siemens AG

Substantially Equivalent

510(k) numberK110366

Submission

Device name: Syngo.Ct Cardiac Function
Applicant: Siemens AG
Mavern, PA, US
Received: February 7, 2011
Decision date: April 12, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: JAK – System, X-Ray, Tomography, Computed
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1750
Specialty: Radiology

Other 510(k)s with product code JAK

510(k)	Device	Applicant	Decision
K253836	FCT iStream Phase 2JAK · Traditional	Fujifilm Corporation	09/04/2026SE
K253450	BodyTom Elite (NL4000)JAK · Traditional	NeuroLogica Corp., a Samsung Company	07/28/2026SE
K253770	CardIQ SuiteJAK · Traditional	GE Medical Systems SCS	07/21/2026SE
K253560	Enhanced Boundary for PCCTJAK · Traditional	Ge Medical Systems, LLC	06/24/2026SE
K253026	Respiratory Gating for Scanners (2.1)JAK · Traditional	Varian Medical Systems, Inc.	06/04/2026SE
K253596	Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional	Canon Medical Systems Corporation	05/20/2026SE
K253649	Spectral CT Verida FamilyJAK · Traditional	Philips Medical Systems Technologies , Ltd.	03/27/2026SE
K253686	True Definition DLJAK · Traditional	Ge Healthcare Japan Corporation	03/23/2026SE
K252992	CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional	Philips Healthcare (Suzhou) Co., Ltd.	03/23/2026SE
K253574	SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional	Siemens Medical Solutions USA, Inc.	03/20/2026SE

More from Siemens Medical Solutions USA, Inc.

510(k)	Device	Decision
K150843	syngo®.via (version VB10A)LLZ · Abbreviated	04/24/2015SE
K123375	Syngo.ViaLLZ · Traditional	11/20/2012SE
K103360	Dimension Vista Digitoxin Calibrator - DGTX CalJIT · Traditional	12/17/2010SE
K081182	Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test - Inducible…JWY · Traditional	08/08/2008SE
K071310	Syngo CT Oncology Software PackageJAK · Traditional	06/08/2007SE
K063507	Syngo Neuro PBV CTJAK · Traditional	11/30/2006SE
K063373	Flex Loop Coil Set 3TMOS · Traditional	11/17/2006SE
K053024	Syngo Neuro Dsa CTJAK · Traditional	11/04/2005SE
K050867	Syngo Body Perfusion-CtJAK · Traditional	04/14/2005SE
K043122	SMD 21500 or DSB-2103-D-5MP-5M Pixel Grayscale Flat Panel DisplayLLZ · Traditional	02/09/2005SE

Questions and answers

When was Syngo.Ct Cardiac Function cleared by the FDA?

Syngo.Ct Cardiac Function (K110366) received a 510(k) decision of Substantially Equivalent on April 12, 2011, 64 days after the submission was received.

What is the product code of K110366?

The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.