(43 days)
K921112/B
Not Found
No
The device description focuses solely on data storage and retrieval, explicitly stating it performs "no data manipulation" and does not mention any AI/ML terms or functionalities.
No.
The device is described as a storage system for medical images and patient identification data. It does not directly diagnose, treat, or mitigate disease, nor does it affect any equipment involved with patient care or come into contact with the patient. Its function is solely data storage and retrieval.
No.
The device is described as a storage system for medical images and patient identification data. It receives data from imaging modalities, stores it, and retrieves it for display on other devices for interpretation. The description explicitly states that the device "does not monitor, control, or affect any equipment that is directly involved with the patient" and "performs no data manipulation." A diagnostic device typically performs analysis or interpretation of data to aid in diagnosis, which this device does not. Its function is limited to data storage and retrieval.
No
The device description explicitly mentions hardware components such as optical disk drives, optical disk libraries, magnetic disks, and connections to other hardware like CRT image consoles and multiformatters. While software is involved in data storage and retrieval, the device is fundamentally a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "storage of FCR image with patient identification data" and storing image and patient identification data from other sources like CT and MRI. This is focused on data management and archiving of medical images.
- Device Description: The description details a system for storing and retrieving medical images and patient data on optical disks. It explicitly states that the device "do not monitor, control, or affect any equipment that is directly involved with the patient" and "do not come in contact with the patient." It also performs "no data manipulation, but store data received from host imaging modalities."
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests or analysis on biological samples.
The device is clearly designed for the storage and retrieval of medical imaging data, which falls under the category of medical imaging systems or picture archiving and communication systems (PACS), not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The subject devices share the intended use of the predicate OD-F623: the storage of FCR image with patient identification data. The subject devices add the additional capability to store image and patient identification data from sources other than computed radiography image readers.
Product codes
Not Found
Device Description
These devices store FCR (Fuji Computed Radiography) and other (for example CT and MRI) image and patient ID data on glass 12-inch (OD-F614 Series) or 5-inch OD-F624 Series optical disks using a single optical disk drive (OD-F614 or OD-F624) or optical disk library (OD-F614L or OD-F624L).
These devices are connected to FCR image reader through HI-C654 CRT image consoles, and connected to other image sources through Fuji multiformatters MF-300L. FCR images are compressed at the transmitter HI-C654 by reversible compression rate: 1:2), transmitted to OD-F614 via the network, and recorded on optical disks. Images data from other modalities are compressed at the multiformatter (compression rate: 1:2), and similarly transmitted to OD-F614 via the network, and recorded on optical disks.
Patient ID data stored on the optical disks is simultaneously recorded on a magnetic disk for database retrieval. Using the database, image data can be retrieved by various criteria according to remote search requests from the image consoles (HI-C654), and transmitted to the image console where it is displayed Ar. " on the CRT as may be printed on film. The subject optical disk filing units do not monitor, control, or affect any equipment that is directly involved with the patical disk filing units do not come in contact with the patient. The optical disk filing units perform no data manipulation, but store data received from host imaging modalities.
Images stored and retrieved from the subject device are expected to be used for primary radiographic interpretation when displayed on a soft- or hard-copy device (not part of this submission). Interpretation provides adequate opportunity for competent human intervention. The level of concern associated with the function of the device is minor; failures or latent design flaws are not expected to result in injuries to patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
FCR (Fuji Computed Radiography) and other (for example CT and MRI)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
For digital image data storage systems, the performance measure bearing on safety and effectiveness is the device's accuracy or data error rate. For the subject and predicate devices, the data error rate (after correction) is 10-12 bit, equivalent to one bit in the data stored in 148 of the new, larger, 12-inch, 7 GB optical disks.
Key Metrics
data error rate (after correction) is 10-12 bit
Predicate Device(s)
K921112/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
1160326
MAR - 7 1996
510(k) Summary [as required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(1)]
January 23, 1996
Submitter's Information [21 CFR 807.92(a)(1)]
Fuji Medical Systems U.S.A., Inc. Post Office Box 120035 Stamford, Connecticut 06912-0035 Telephone: +1 203 353 0300 facsimile: +1 203 353 0145 Contact: Robert A. Uzenoff
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|
The device trade name is Fuji Computed Radiography) DMS Optical Disk Image Filing Unit OD-F6X4/L Series and Multimodality System. The Series includes models OD-F614, OD-F624, OD-F624L, and Fuji Multimodality Systems. FCR® is a registered trademark of Fuji Photo Film Co., Ltd., Inc. The device common name optical disk file system.
Predicate Device [21 CFR 807.92(a)(3)]
Fuji identifies the predicated device as the Fuji FCR DMS OD-F623. FDA assigned the predicate Fuji FCR DMS OD-F623 to regulatory class II, with FDA product code RA 90 KPR (system, X-ray, stationary) citing 21 CFR § 892.1680.
FDA's accession number for the predicate device is K921112/B. FDA cleared the marketing of the predicate device in a letter dated April 27, 1993.
Description of the Device [21 CFR 807.92(a)(4)]
These devices store FCR (Fuji Computed Radiography) and other (for example CT and MRI) image and patient ID data on glass 12-inch (OD-F614 Series) or 5-inch OD-F624 Series optical disks using a single optical disk drive (OD-F614 or OD-F624) or optical disk library (OD-F614L or OD-F624L).
These devices are connected to FCR image reader through HI-C654 CRT image consoles, and connected to other image sources through Fuji multiformatters MF-300L. FCR images are compressed at the transmitter HI-C654 by reversible compression rate: 1:2), transmitted to OD-F614 via the network, and recorded on optical disks. Images data from other modalities are compressed at the multiformatter (compression rate: 1:2), and similarly transmitted to OD-F614 via the network, and recorded on optical disks.
Patient ID data stored on the optical disks is simultaneously recorded on a magnetic disk for database retrieval. Using the database, image data can be retrieved by various criteria according to remote search requests from the image consoles (HI-C654), and transmitted to the image console where it is displayed
Fuji OD-F6X4/L Series 9 1996 January 23
1
Ar. " on the CRT as may be printed on film. The subject optical disk filing units do not monitor, control, or affect any equipment that is directly involved with the patical disk filing units do not come in contact with the patient. The optical disk filing units perform no data manipulation, but store data received from host imaging modalities.
Images stored and retrieved from the subject device are expected to be used for primary radiographic interpretation when displayed on a soft- or hard-copy device (not part of this submission). Interpretation provides adequate opportunity for competent human intervention. The level of concern associated with the function of the device is minor; failures or latent design flaws are not expected to result in injuries to patients.
Intended Use [21 CFR 807.92(a)(5)]
The subject devices share the intended use of the predicate OD-F623: the storage of FCR image with patient identification data. The subject devices add the additional capability to store image and patient identification data from sources other than computed radiography image readers.
Technological Characteristics [21 CFR 807.92(a)(6)}
The subject OD-F6X4/L Series optical disk filing units are similar in design and composition to the predicate OF-F623. The OD-F614/L Series media is 12 inch glass optical disks with improved storage characteristics. The data error rate after correction is 1014 bit, equivalent to one bit in the data stored in 148 of the larger, 12-inch, 7 GB optical disks.
Performance Data [21 CFR 807.92(b)(1)]
For digital image data storage systems, the performance measure bearing on safety and effectiveness is the device's accuracy or data error rate. For the subject and predicate devices, the data error rate (after correction) is 10-12 bit, equivalent to one bit in the data stored in 148 of the new, larger, 12-inch, 7 GB optical disks. ಿ
Conclusion [21 CFR 807.92(b)(3)l
Conclusion [21 CFR 807.92(b)(3)]
The Fuji OD-F6X4/L Series optical disk filing units have the same design and operating characteristics as the predicate device and, with the same data error rates, will be as safe arid effective as the predicate Fuji OD-F623.