FDA.reportPublic FDA data

PICA Whole-body MRI System

Primary DI
00862694000304
Brand
PICA Whole-body MRI System
Company
TIME MEDICAL SYSTEMS
Model
TMS-MRI-3500wb-02
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110942000PICA WHOLE-BODY MRI SYSTEMTime Medical Limited2011-07-26LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862694000304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862694000304008626940003048626940003040862694000304

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, permanent magnetA general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly and can be fixed-location, mobile, or transportable. In addition to producing conventional MR images, it can be designed or modified through additional software/hardware to perform MR spectroscopy and other real-time imaging procedures necessary for physiologically gated imaging procedures, or MRI mammography and other MRI guided interventional, therapeutic, or surgical applications. It is available in a variety of gantry configurations including closed bore, open bore, open-sided or other patient accessible designs.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight18500Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 858-458-0166sales@time-medical.com
+1 650-689-5289sales@time-medical.com

Regulatory Flags#

DUNS number
020884437
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862694000328NEONA 1.5T MRI System15000-022023-03-22
00862694000311EMMA 1.5T MRI System15000-012023-03-16

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Primary DI, Brand, Company table
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00884838133235dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133242dS MSK S 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
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