Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2320968

FEI Number

3003318268

Entity Name

RBM SERVICES, LLC.

City/State/Country

OAK RIDGE, TN, US

Establishment Address

101 Valley Ct Ste B, OAK RIDGE, TN 37830, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RBM SERVICES, LLC. (Owner Number: 9044762)

Owner / Operator Contact Address

101-B VALLEY COURT, --, Oak Ridge, TN 37830, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HeartSee Cardiac P.E.T.Processing Software SRT-100+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2014-07-28
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2019-06-04
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2018-05-24

Official Correspondent

TARAH BOLAS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RBM SERVICES, LLC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241174	Carl Zeiss Meditec, AG	INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)	2025-01-10
K033956	Is2 Research, Inc.	MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)	2004-01-20
K923309	GE Medical Systems	ARGUS PET SYSTEM	1992-09-29
K101768	Miegmbh	MIE SCINTRON GAMMA CAMERA SYSTEMS	2010-10-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2018	Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany	2	Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
Z-0005-2016	Toshiba American Medical Systems Inc	2	Celesteion PCA-9000A/2 PET/CT System
Z-0012-05	General Electric Med Systems LLC	2	Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Z-0013-2007	Philips Medical Systems (Cleveland) Inc	2	Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
Z-0014-2007	Philips Medical Systems (Cleveland) Inc	2	Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.

Similar Registrations

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9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2320968. Last updated year: 2026. Please use registration number 2320968 when referencing this establishment in official correspondence.