FDA.reportPublic FDA data

SONY

Primary DI
04548736103160
Brand
SONY
Company
SONY CORPORATION
Model
HVO-550MD
Device description
HD VIDEO RECORDER
Published
2020-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LMBDevice, Digital Image Storage, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMBDevice, Digital Image Storage, RadiologicalRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961680000SONY DKR-700 DIGITAL STILL RECORDERSony Medical Systems1996-07-03LMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548736103160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548736103160045487361031604548736103160

GMDN Terms#

Term, Definition table
TermDefinition
Medical video image recorderAn electrically-powered device designed to be used in conjunction with video endoscopes, radiological equipment, and/or surgical video imaging devices (e.g., surgical microscope, camera) to digitally record video images; it may incorporate a small screen intended to reference what images are being captured, but not intended to be used as a monitor. It is typically a portable device with a direct electronic signal connection to the diagnostic/surgical device and may include playback and/or storage file capabilities; it is not intended to distribute image data within a network (i.e., not a medical image management system).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690553649
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548736183407SONYLMD-XH320T2026-04-30
04548736183414SONYLMD-XH550T2026-04-30
04548736155978SONYUP-D899MD2025-11-04
04548736155985SONYUP-X899MD2025-11-04
04548736169968SONYUP-D899DC2025-11-04
04548736169951SONYUP-D899DC2025-10-06
04548736155091SONYUP-D899MD2025-09-30
04548736155107SONYUP-X899MD2025-09-30
04548736170735SONYLMD-43M1MD2025-09-30
04548736170759SONYLMD-43M1N2025-09-30
04548736170698SONYLMD-27M1MD2025-09-12
04548736170711SONYLMD-27M1N2025-09-12
04548736170728SONYLMD-43M1MD2025-07-08
04548736170742SONYLMD-43M1N2025-07-08
04548736170681SONYLMD-27M1MD2025-06-24
04548736170704SONYLMD-27M1N2025-06-24
04548736167117SONYLMD-32M1MD2025-05-30
04548736167124SONYLMD-32M1N2025-05-30
04548736166059SONYLMD-32M1N2025-04-01
04548736166325SONYLMD-32M1MD2025-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047074816CuratOREIZO CORPORATIONLMB2026-05-29
00850631008858Roentgen WorksBrit Systems, LLCLMB2026-05-26
00745426000028MiPACS Storage ServerApryse Software Corp.LMB2026-04-27
00850631008834Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008841Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008827Roentgen WorksBrit Systems, LLCLMB2026-03-05
04907034602476UR-4MDTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2026-01-09
00850631008810Roentgen WorksBrit Systems, LLCLMB2026-01-01
00850631008803Roentgen WorksBrit Systems, LLCLMB2025-12-11
00850631008797Roentgen WorksBrit Systems, LLCLMB2025-11-20
00850631008766Roentgen WorksBrit Systems, LLCLMB2025-10-01
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMB2025-09-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMB2025-09-18
00850631008759Roentgen WorksBrit Systems, LLCLMB2025-08-14
00850631008742Roentgen WorksBrit Systems, LLCLMB2025-08-07
00850631008735Roentgen WorksBrit Systems, LLCLMB2025-07-31
04907034602155UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602162UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602230UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602247UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602254UR-NEXT4KSTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602261UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602278UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602285UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602308UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602315UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602322UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602339UR-4MDDongguan Teac Electronics Co., Ltd.LMB2025-07-31
04907034602346UR-NEXT4KHTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31
04907034602353UR-NEXT4KSTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2025-07-31